← Back to catalogue
Bone Management
EUDAMEDFDA UDIClass I (EU MDR)
Ref RA1TRModel Accessories implantology and oral surgeryRef TSBOX001Model Bur blocks and traysRef GS6KTRef BWTSIRef HN008 050Ref IET03Ref BWT04Ref IET01Ref MP32Ref BNT00Ref GTAOTRef HI100Ref BWTSORef BSS37Ref MSBOXRef 36TCT09013Model Products for bone fixationRef 39MSS10140Ref 39MST12060Ref 36TCT10013Ref 36TCT10010Ref 36TCT09007Ref 39MSS12080Ref 36TS035040040Ref 36BSP000050Model Products for membrane fixationRef 39MSS12040Ref 39MSS10080Ref 39MSS10120Ref 36BMP000030Ref 36US070040090Ref 36CP110Ref 39MST10060Ref 39MSS12120Ref 39MST10080Ref 39MSS12140Ref 36US050040090Ref 36US050040110
Identity
- Trade Name
- Bone Management EUDAMEDFDA UDIScrew TX, dental FDA UDIn/a FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDISurgical drill guide, reusable FDA UDICraniofacial bone screw, non-bioabsorbable FDA UDI
- Device Name
- Screw for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 13mm, diameter 1.1mm, core diameter 0.9mm The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. FDA UDIScrew for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 10mm, diameter 1.3mm, core diameter 1.0mm The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. FDA UDIManual instrument for dental/surgical application FDA UDIScrew for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 7mm, diameter 1.1mm, core diameter 0.9mm The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. FDA UDIMICRO-SCREW ST Ø1.2 L 12.0 FDA UDIMICRO-SCREW ST Ø1.0 L 14.0 FDA UDIMICRO-SCREW ST Ø1.0 L 8.0 FDA UDIMICRO-SCREW ST Ø1.0 L 12.0 FDA UDIMICRO-SCREW ST Ø1.0 L 4.0 FDA UDIScrew for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 13mm, diameter 1.3mm, core diameter 1.0mm The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. FDA UDIMICRO-SCREW ST Ø1.2 L14 FDA UDIMICRO-SCREW ST Ø1.2 L 8.0 FDA UDIMICRO-SCREW ST Ø1.2 L 4.0 FDA UDI
- Model / Reference
- Accessories implantology and oral surgery EUDAMEDRA1TR EUDAMEDBur blocks and trays EUDAMEDTSBOX001 EUDAMEDGS6KT EUDAMEDBWTSI EUDAMEDHN008 050 EUDAMEDIET03 EUDAMEDBWT04 EUDAMEDIET01 EUDAMEDMP32 EUDAMEDBNT00 EUDAMEDGTAOT EUDAMEDHI100 EUDAMEDBWTSO EUDAMEDBSS37 EUDAMEDMSBOX EUDAMEDProducts for bone fixation EUDAMED36TCT09013 EUDAMED39MSS10140 EUDAMED39MST12060 EUDAMED36TCT10013 EUDAMED36TCT10010 EUDAMED36TCT09007 EUDAMED39MSS12080 EUDAMED36TS035040040 EUDAMEDProducts for membrane fixation EUDAMED36BSP000050 EUDAMED39MSS12040 EUDAMED39MSS10080 EUDAMED39MSS10120 EUDAMED36BMP000030 EUDAMED36US070040090 EUDAMED36CP110 EUDAMED39MST10060 EUDAMED39MSS12120 EUDAMED39MST10080 EUDAMED39MSS12140 EUDAMED36US050040090 EUDAMED36US050040110 EUDAMEDTCT09 013 FDA UDITCT10 010 FDA UDIHN008 050 FDA UDITCT09 007 FDA UDIMSS12 12 FDA UDIMSS10 14 FDA UDIMSS10 8 FDA UDIMSS10 12 FDA UDIMSS10 4 FDA UDITCT10 013 FDA UDIMSS12 14 FDA UDIMSS12 8 FDA UDIMSS12 4 FDA UDI
- Description
- Screw for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 13mm, diameter 1.1mm, core diameter 0.9mm The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. FDA UDIScrew for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 10mm, diameter 1.3mm, core diameter 1.0mm The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. FDA UDIManual instrument for dental/surgical application FDA UDIScrew for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 7mm, diameter 1.1mm, core diameter 0.9mm The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. FDA UDIMICRO-SCREW ST Ø1.2 L 12.0 FDA UDIMICRO-SCREW ST Ø1.0 L 14.0 FDA UDIMICRO-SCREW ST Ø1.0 L 8.0 FDA UDIMICRO-SCREW ST Ø1.0 L 12.0 FDA UDIMICRO-SCREW ST Ø1.0 L 4.0 FDA UDIScrew for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 13mm, diameter 1.3mm, core diameter 1.0mm The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile. FDA UDIMICRO-SCREW ST Ø1.2 L14 FDA UDIMICRO-SCREW ST Ø1.2 L 8.0 FDA UDIMICRO-SCREW ST Ø1.2 L 4.0 FDA UDI
Identifiers
- Catalog Number
- TCT09 013 FDA UDITCT10 010 FDA UDIHN008 050 FDA UDITCT09 007 FDA UDIMSS12 12 FDA UDIMSS10 14 FDA UDIMSS10 8 FDA UDIMSS10 12 FDA UDIMSS10 4 FDA UDITCT10 013 FDA UDIMSS12 14 FDA UDIMSS12 8 FDA UDIMSS12 4 FDA UDI
- Primary DI / UDI-DI
- E0HM39RA1TR1 EUDAMEDE0HM82TSBOX0011 EUDAMEDE0HM39GS6KT0000251 EUDAMEDE0HM82BWTSI1 EUDAMEDE0HM36HN0080400501 EUDAMEDFDA UDIE0HM39IET030530271 EUDAMEDE0HM82BWT041 EUDAMEDE0HM39IET010370221 EUDAMEDE0HM82BMP000321 EUDAMEDE0HM82BNT00BB1 EUDAMEDE0HM82GTAOT1 EUDAMEDE0HM39HI1001 EUDAMEDE0HM82BWTSO1 EUDAMEDE0HM82BSS371 EUDAMEDE0HM39GS6KT0000161 EUDAMEDE0HM82MSBOX0121 EUDAMEDE0HM39IET030530221 EUDAMEDE0HM36TCT090131 EUDAMEDFDA UDIE0HM36TCT100101 EUDAMEDFDA UDIE0HM36TCT090071 EUDAMEDFDA UDIE0HM39MSS121201 EUDAMEDFDA UDIE0HM39MSS101401 EUDAMEDFDA UDIE0HM39MSS100801 EUDAMEDFDA UDIE0HM39MSS101201 EUDAMEDFDA UDIE0HM36TCT100131 EUDAMEDFDA UDIE0HM39MSS121401 EUDAMEDFDA UDIE0HM39MSS120801 EUDAMEDFDA UDIE0HM39MSS120401 EUDAMEDFDA UDIE0HM39MST120601 EUDAMEDE0HM36TS0350400401 EUDAMEDE0HM36BSP0000501 EUDAMEDE0HM36BMP0000301 EUDAMEDE0HM36US0700400901 EUDAMEDE0HM36CP1101 EUDAMEDE0HM39MST100601 EUDAMEDE0HM39MST100801 EUDAMEDE0HM36US0500400901 EUDAMEDE0HM36US0500401101 EUDAMEDE0HM39MSS100401 FDA UDI
- Basic UDI-DI
- ++E0HM351I05AAPZ EUDAMED++E0HM400I01AALW EUDAMED++E0HM400I00AALR EUDAMED++E0HM351I01ABPF EUDAMED++E0HM351I10AKQ3 EUDAMED++E0HM400I00ABLT EUDAMED++E0HM220IIB00AAYJ EUDAMED++E0HM220IIB01ABYR EUDAMED++E0HM225IIB00AA3L EUDAMED
- Direct Marketing DI
- E0HM82TSBOX0011 EUDAMEDE0HM82BMP000321 EUDAMEDE0HM82MSBOX0121 EUDAMED
- FDA Product Code
- DZL FDA UDINDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMEDV0480 CLINICAL USE CONTAINERS (NON-IVD) - ACCESSORIES EUDAMEDP09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMEDP09120604 OSTEOSYNTHESIS NAIL-SCREW SYSTEMS EUDAMED
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDISurgical drill guide, reusable FDA UDICraniofacial bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4880 FDA UDI872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Bone Management by Hager & Meisinger GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E0HM351I05AAPZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hager & Meisinger GmbH
- EUDAMED SRN
- DE-MF-000004966
Sources (51)
- EUDAMED a684347e-6ba8-45fc-965c-e060125894d9 61 fields · synced Oct 6, 2026
- EUDAMED e142bd07-1bb4-46d0-8be4-417539e74a67 61 fields · synced May 11, 2026
- EUDAMED 922aa764-a2d3-47bf-a45b-51e080ac6501 61 fields · synced May 16, 2026
- EUDAMED 59a3dceb-2524-4412-a8bf-efc64d4502c7 61 fields · synced May 17, 2026
- EUDAMED 23f46a57-76a7-4213-9514-b9c85d8f525a 61 fields · synced May 17, 2026
- EUDAMED 571a627a-edad-4f61-9841-3f605bbf940f 61 fields · synced May 17, 2026
- EUDAMED 8fe63508-b28d-493b-ba70-6f1aa1b82adb 61 fields · synced May 17, 2026
- EUDAMED 588ab9ec-16b4-495c-9f17-19d77809bf07 61 fields · synced May 17, 2026
- EUDAMED 74b8dcb0-4855-43a2-b069-4049f311c4c4 61 fields · synced May 17, 2026
- EUDAMED 7a9c9abd-4589-4b85-a432-b50ebd43fb4c 61 fields · synced May 17, 2026
- EUDAMED c43c77cf-dd8c-4207-9b18-a925135c4ea1 61 fields · synced May 18, 2026
- EUDAMED 1c559d66-7cf0-4a4b-8518-30f9ab36928b 61 fields · synced May 18, 2026
- EUDAMED 8304801c-4a5c-46bc-8bee-2370f24a8028 61 fields · synced May 18, 2026
- EUDAMED b44d37e4-bbcc-4ec1-b0a3-2c288a88a000 61 fields · synced May 18, 2026
- EUDAMED 3a17e1aa-3bd7-4b30-9133-e803ba2821a7 61 fields · synced May 18, 2026
- EUDAMED 82505327-b766-433a-b01b-c25242de4c9d 61 fields · synced May 18, 2026
- EUDAMED 1724a6be-a181-451a-a440-e2157fc7eae8 61 fields · synced May 19, 2026
- FDA UDI 570c332e-7cb0-4c8b-a896-49e5cd0af19b 36 fields · synced May 22, 2026
- FDA UDI 195d65db-a013-47fa-8be8-e9285efc41a1 36 fields · synced May 24, 2026
- FDA UDI 6a7f1127-32e6-4ba3-ba71-2935f2b4c6bc 35 fields · synced May 24, 2026
- FDA UDI 997a9d69-8804-4ef1-8a27-7dae90f3232d 36 fields · synced May 29, 2026
- FDA UDI 1dd42b60-f983-4db2-adfc-80387a448886 36 fields · synced May 29, 2026
- FDA UDI 16a90fd6-213c-48ee-be9e-d98ad4dc3957 36 fields · synced May 30, 2026
- FDA UDI f4dead3c-52b5-409c-9f99-69cd68c0c0a6 36 fields · synced May 30, 2026
- FDA UDI 47d17257-a536-495b-9b69-8fa74ad981ec 36 fields · synced May 30, 2026
- FDA UDI 75e39fe1-ec37-4d8c-98cd-1ba10cc74b20 36 fields · synced May 30, 2026
- FDA UDI 6f18cd40-0feb-4d36-a7bb-77c29b2d9362 36 fields · synced May 30, 2026
- FDA UDI 9ab4b8a0-b3bb-426d-9539-3ce5f099c0e3 36 fields · synced May 30, 2026
- FDA UDI 856eeb32-88d9-442a-ab71-06f623fe35b6 36 fields · synced May 30, 2026
- FDA UDI 4fc93852-9f15-4a75-b816-300682adfcda 36 fields · synced May 30, 2026
- EUDAMED 799ef8e7-189e-4641-8b4a-654b7a97b8e4 61 fields · synced Jun 20, 2026
- EUDAMED 20c20c97-f419-4b68-8083-eaf42015abfd 61 fields · synced Jun 20, 2026
- EUDAMED a03835d6-9c3b-4093-ad4c-a7f2480f06f5 61 fields · synced Jul 9, 2026
- EUDAMED eb416c5b-17ad-4f68-8e69-864e0beb4cb0 61 fields · synced Jul 9, 2026
- EUDAMED 7a11fc17-7348-4e51-a414-126cf79ec67d 61 fields · synced Jul 9, 2026
- EUDAMED 5735bf21-4067-404b-b1b6-1548901eec99 61 fields · synced Jul 9, 2026
- EUDAMED 064fc968-f723-40bd-88b6-7a6189cc7aa0 61 fields · synced Jul 9, 2026
- EUDAMED e910eafc-fe3f-45d1-be2b-e54e20042010 61 fields · synced Jul 10, 2026
- EUDAMED 34107045-78ef-4774-8cff-019a8c41d0f8 61 fields · synced Jul 10, 2026
- EUDAMED fc87ed35-dc66-421d-b70d-f01853cff87d 61 fields · synced Jul 11, 2026
- EUDAMED 9b3aea33-be14-43c4-b05f-846750382c32 61 fields · synced Jul 11, 2026
- EUDAMED 33fd92e7-e332-4d3f-88ea-6358535f7288 61 fields · synced Jul 11, 2026
- EUDAMED 11690256-85fc-4971-a19b-4d6b5b55d44c 61 fields · synced Jul 12, 2026
- EUDAMED 9745c27d-4754-4579-a9a0-d1c6d79d6769 61 fields · synced Jul 17, 2026
- EUDAMED db5d9fc6-f1fb-4342-8e29-44a729a565e0 61 fields · synced Jul 17, 2026
- EUDAMED 9d417b97-8600-4bde-8a84-3936aabe7ae5 61 fields · synced Jul 18, 2026
- EUDAMED dc172fa6-ff65-4c8d-b69c-a5e9cc2227c8 61 fields · synced Jul 19, 2026
- EUDAMED f391ab2c-c97d-48c0-91ae-18a12795f871 61 fields · synced Jul 19, 2026
- EUDAMED 554a4978-59c8-4a64-befb-67a24cf942c5 61 fields · synced Jul 27, 2026
- EUDAMED b97af3e6-75d1-4c38-b813-659508f35b6b 61 fields · synced Jul 28, 2026
- EUDAMED 3558d85f-9e9f-4818-b0fc-3625843cb42d 61 fields · synced Jul 31, 2026