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Ibs-B
EUDAMEDFDA UDIClass I (EU MDR)
Ref G01 N0081Ref G01 N0191Ref G01 N0111Ref G01 N0131Ref G01 N0073Ref G01 401A00Ref G01 N0072Ref G01 N0201Ref G01 N0132Ref G01 N0062Ref G01 N0085Ref G01 N0093Ref G01 N0091Ref G01 N0061Ref C01 S2016Ref G01 N0152Ref G01 403A00Ref G01 402A01Ref G01 N0151Ref G01 N0063Ref G01 N0083
Identity
- Trade Name
- IBS-B EUDAMEDFDA UDIIBS EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDIOrthopaedic bur, reusable FDA UDIOrthopaedic surgical procedure kit, non-medicated, single-use FDA UDISurgical screwdriver, reusable FDA UDI
- Device Name
- Non-patient-contacting Class I instruments, Non-Active EUDAMEDBeveled Screw Sterile Instruments, Active EUDAMEDScrewsDia.3.3 andDia.4.0 soft tissues protector, Non-Sterile FDA UDIScrewsDia.6.5 soft tissues protector, Non-Sterile FDA UDICountersink for screwsDia.3.3mm, Non-Sterile FDA UDIIBS-B Targeting Guide - Locking Wheel Sliding arm extension FDA UDIIBS B SYSTEM BEVELED SCREWDRIVER T10 - AO ATTACHMENT FDA UDIIBS-BDia.1.6mm K-Wires, 130 and 200mm, 2ea FDA UDINon-beveled screwdriver T10 - AO attachment, Non-Sterile FDA UDIBeveled screwdriver T25 - SMALL HUDSON attachment, NS FDA UDIIBS-B Targeting Guide - Locking Wheel for Sliding arm FDA UDIBeveled screwdriver T10 - AO attachment, Non-Sterile FDA UDINon-beveled screwdriver T25 - SMALL HUDSON attachment, NS FDA UDIScrewsDia.3.3 andDia.4.0 K-wire protector, Non-Sterile FDA UDIIBS-B Targeting Guide - Measurer FDA UDIIBS B SYSTEM BEVELED SCREWDRIVER T15 - AO ATTACHMENT FDA UDIDrill for screwsDia.4.0mm, Non-Sterile FDA UDICountersink for screwsDia.4.0mm, Non-Sterile FDA UDIIBS-B Targeting Guide - K-Wire Sleeve FDA UDIDrill for screwsDia.6.5mm, Non-Sterile FDA UDICountersink for screwsDia.6.5mm, Non-Sterile FDA UDI
- Model / Reference
- G01 N0081 EUDAMEDFDA UDIG01 N0191 EUDAMEDFDA UDIG01 N0111 EUDAMEDFDA UDIG01 N0131 EUDAMEDFDA UDIG01 N0073 EUDAMEDFDA UDIG01 401A00 EUDAMEDG01 N0072 EUDAMEDFDA UDIG01 N0201 EUDAMEDFDA UDIG01 N0132 EUDAMEDFDA UDIG01 N0062 EUDAMEDFDA UDIG01 N0085 EUDAMEDFDA UDIG01 N0093 EUDAMEDFDA UDIG01 N0091 EUDAMEDFDA UDIG01 N0061 EUDAMEDFDA UDIC01 S2016 EUDAMEDFDA UDIG01 N0152 EUDAMEDFDA UDIG01 403A00 EUDAMEDG01 N0083 EUDAMEDFDA UDIG01 N0151 EUDAMEDFDA UDIG01 N0063 EUDAMEDFDA UDIG01 402A01 EUDAMEDG01 N0084 FDA UDI
- Description
- ScrewsDia.3.3 andDia.4.0 soft tissues protector, Non-Sterile FDA UDIScrewsDia.6.5 soft tissues protector, Non-Sterile FDA UDICountersink for screwsDia.3.3mm, Non-Sterile FDA UDIIBS-B Targeting Guide - Locking Wheel Sliding arm extension FDA UDIIBS B SYSTEM BEVELED SCREWDRIVER T10 - AO ATTACHMENT FDA UDIIBS-BDia.1.6mm K-Wires, 130 and 200mm, 2ea FDA UDINon-beveled screwdriver T10 - AO attachment, Non-Sterile FDA UDIBeveled screwdriver T25 - SMALL HUDSON attachment, NS FDA UDIIBS-B Targeting Guide - Locking Wheel for Sliding arm FDA UDIBeveled screwdriver T10 - AO attachment, Non-Sterile FDA UDINon-beveled screwdriver T25 - SMALL HUDSON attachment, NS FDA UDIScrewsDia.3.3 andDia.4.0 K-wire protector, Non-Sterile FDA UDIIBS-B Targeting Guide - Measurer FDA UDIIBS B SYSTEM BEVELED SCREWDRIVER T15 - AO ATTACHMENT FDA UDIDrill for screwsDia.4.0mm, Non-Sterile FDA UDICountersink for screwsDia.4.0mm, Non-Sterile FDA UDIIBS-B Targeting Guide - K-Wire Sleeve FDA UDIDrill for screwsDia.6.5mm, Non-Sterile FDA UDICountersink for screwsDia.6.5mm, Non-Sterile FDA UDI
Identifiers
- Catalog Number
- G01 N0131 FDA UDIG01 N0132 FDA UDIG01 N0061 FDA UDIG01 N0152 FDA UDIG01 N0084 FDA UDIC01 S2016 FDA UDIG01 N0091 FDA UDIG01 N0083 FDA UDIG01 N0151 FDA UDIG01 N0081 FDA UDIG01 N0093 FDA UDIG01 N0111 FDA UDIG01 N0201 FDA UDIG01 N0085 FDA UDIG01 N0072 FDA UDIG01 N0062 FDA UDIG01 N0191 FDA UDIG01 N0073 FDA UDIG01 N0063 FDA UDI
- Primary DI / UDI-DI
- 00810021867847 EUDAMEDFDA UDI00810021868097 EUDAMEDFDA UDI00810021867960 EUDAMEDFDA UDI00810021867984 EUDAMEDFDA UDI00810021867830 EUDAMEDFDA UDI00810021868127 EUDAMED00810021867816 EUDAMEDFDA UDI00810021868103 EUDAMEDFDA UDI00810021868011 EUDAMEDFDA UDI00810021867762 EUDAMEDFDA UDI00810021867939 EUDAMEDFDA UDI00810021869742 EUDAMEDFDA UDI00810021867861 EUDAMEDFDA UDI00810021867748 EUDAMEDFDA UDI00810021867663 EUDAMEDFDA UDI00810021868042 EUDAMEDFDA UDI00810021868141 EUDAMED00810021867922 EUDAMEDFDA UDI00810021868035 EUDAMEDFDA UDI00810021867786 EUDAMEDFDA UDI00810021868134 EUDAMED00810021869759 FDA UDI
- Basic UDI-DI
- 08101755051447 EUDAMED08101755028147 EUDAMED08101755028045 EUDAMED
- FDA Product Code
- LXH FDA UDIFZX FDA UDIKDD FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMEDL0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMEDL091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMEDV0480 CLINICAL USE CONTAINERS (NON-IVD) - ACCESSORIES EUDAMEDP091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDIOrthopaedic bur, reusable FDA UDIOrthopaedic surgical procedure kit, non-medicated, single-use FDA UDISurgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- Regulation Number
- 888.4540 FDA UDI878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
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
Yes
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Acetabular orthopaedic reamer
Ibs-B by In2Bones, USA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Acetabular orthopaedic reamer.
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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 | 08101755051447 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- In2Bones, USA
- EUDAMED SRN
- US-MF-000023092
- Authorised Representative
- Conmed Europe BV BE-AR-000035662
Sources (57)
- EUDAMED b6030e48-1d17-4fe9-b528-2c8e9ef827bb 61 fields · synced Sep 17, 2026
- EUDAMED f12d3c68-0b06-4f30-b2da-726b1355ed5f 61 fields · synced May 16, 2026
- EUDAMED 73b02008-af09-4f18-b4ae-0f26792c7b16 61 fields · synced May 16, 2026
- EUDAMED f046e2bf-b5b4-4932-a267-815b2d158c7c 61 fields · synced May 17, 2026
- EUDAMED 52e2a343-d5fc-4992-866c-0b6c9251ef5e 61 fields · synced May 17, 2026
- EUDAMED 0ae39526-ad30-4364-bf34-95734e752122 61 fields · synced May 17, 2026
- EUDAMED a485de06-2a77-4ae3-a9fc-e3f9279c2deb 61 fields · synced May 17, 2026
- EUDAMED f579dbcf-fb2e-4274-b653-3ff4767ef99d 61 fields · synced May 17, 2026
- EUDAMED b9558eba-ece2-441a-974f-c08794c0954a 61 fields · synced May 17, 2026
- EUDAMED 36f62f31-8ea2-4587-989d-ad1756f61eee 61 fields · synced May 17, 2026
- EUDAMED 553ca758-b210-4794-ac90-a8ca6011bc48 61 fields · synced May 17, 2026
- EUDAMED cd66b720-69dc-440b-9b44-085d46e1f5f1 61 fields · synced May 18, 2026
- EUDAMED e503f64b-774b-49ca-a76d-7158bce84412 61 fields · synced May 18, 2026
- EUDAMED c3d9769d-eedb-4735-8602-17edffa12ad1 61 fields · synced May 18, 2026
- EUDAMED e13a07fe-7a5a-4d07-81b8-b99a233d8912 61 fields · synced May 18, 2026
- EUDAMED e4d56c14-eb1f-4350-a1f9-e58d1a5b9018 61 fields · synced May 18, 2026
- EUDAMED 3d8b5122-c6ea-4464-8d2e-4954e8d7a9c3 61 fields · synced May 18, 2026
- FDA UDI 5c89c998-5730-418c-9f5f-8b91a715b408 35 fields · synced May 29, 2026
- FDA UDI 0b23d120-dc0d-4ea9-8ab2-bf6042073aa1 35 fields · synced May 30, 2026
- FDA UDI 7059e984-39d1-41a4-905b-c7db59e441b8 35 fields · synced May 30, 2026
- FDA UDI 9740b370-8797-4e42-a566-bedebfa58ede 35 fields · synced May 30, 2026
- FDA UDI 51781736-b8a0-4acb-9d91-74f6c5ac0922 35 fields · synced May 30, 2026
- FDA UDI ba4dbbc5-a034-4e42-90c9-a0f56900ef50 35 fields · synced May 30, 2026
- FDA UDI 2ebe538b-3577-4144-8e72-08873f5fc669 35 fields · synced May 30, 2026
- FDA UDI 608787b9-45b1-4741-9a59-e49d34a2128a 35 fields · synced May 30, 2026
- FDA UDI 9f548160-c491-4bdf-89db-46e9a0a4eaa6 35 fields · synced May 30, 2026
- FDA UDI e0703f55-6d49-4812-bcc8-5bf0e3a16cc8 35 fields · synced May 30, 2026
- FDA UDI ad0015a0-6531-4804-84a5-1b457ce5bc76 35 fields · synced May 30, 2026
- FDA UDI f7bc3e9e-c53d-495f-bce9-48fbefff88c7 35 fields · synced May 30, 2026
- FDA UDI 207b7620-ceff-4354-a825-976b52674fda 35 fields · synced May 30, 2026
- FDA UDI d6275617-1732-4ef4-b089-b1b60fa7a066 35 fields · synced May 30, 2026
- FDA UDI 3d7f37d0-d492-4846-a129-1bc448460833 35 fields · synced May 30, 2026
- FDA UDI aabe47c9-dba7-47f2-86e1-a4433c95175b 35 fields · synced May 30, 2026
- FDA UDI 3ad1e811-001e-4c52-947b-5cccdb926ff5 35 fields · synced May 30, 2026
- FDA UDI 20fe004f-61f8-4762-929d-fa8655a38dd8 35 fields · synced May 30, 2026
- FDA UDI 0483c5a3-e85e-4568-a237-da0bdddfee4b 35 fields · synced May 30, 2026
- EUDAMED 11bb51d6-6afd-4370-85e9-d65d52fab06c 61 fields · synced Jun 20, 2026
- EUDAMED 11b8c331-db1b-4302-b1e0-a0966e870666 61 fields · synced Jul 9, 2026
- EUDAMED a2b7d4d9-ac01-47be-9891-83c801176b49 61 fields · synced Jul 9, 2026
- EUDAMED 70469dfe-417d-4571-9c1a-4cb8a51259f4 61 fields · synced Jul 10, 2026
- EUDAMED c1f4efc9-1406-426e-8d6e-cc00bd670e9a 61 fields · synced Jul 12, 2026
- EUDAMED 86c5504b-879e-49b6-980f-2bc712573f5a 61 fields · synced Jul 14, 2026
- EUDAMED d18e3c37-129e-49f2-a526-cab3fd3e2c09 61 fields · synced Jul 15, 2026
- EUDAMED 6723ebb3-af13-4c31-8043-6d5a43cc8ee3 61 fields · synced Jul 16, 2026
- EUDAMED 9cf67039-81ac-455d-aaf7-e5fbdbe9c3ab 61 fields · synced Jul 17, 2026
- EUDAMED 5f39ecd5-7d8b-4052-9028-a56195e7c466 61 fields · synced Jul 24, 2026
- EUDAMED 6f6a01c1-dc21-4731-82f0-4a7b14eaab43 61 fields · synced Jul 26, 2026
- EUDAMED 09ca127e-e59b-47be-935c-74463d840c1f 61 fields · synced Jul 28, 2026
- EUDAMED 72f693f6-b228-4f4a-a0e4-3c359fce20f6 61 fields · synced Jul 28, 2026
- EUDAMED b2254a9b-5258-4ffa-b525-24aa67e2fcd3 61 fields · synced Jul 28, 2026
- EUDAMED 9382f624-f0e8-4cdd-b6b2-9c65524e63ee 61 fields · synced Jul 28, 2026
- EUDAMED 06573da3-d818-42fe-b254-715a2f5a08f3 61 fields · synced Jul 29, 2026
- EUDAMED c8276b18-6556-41e2-8b88-5d7ed51e429f 61 fields · synced Jul 30, 2026
- EUDAMED 85d652f2-61c6-4174-a2b9-7dc1670554f1 61 fields · synced Jul 30, 2026
- EUDAMED 172af2ed-9735-433c-bc75-3c9395575e90 61 fields · synced Aug 1, 2026
- EUDAMED 363e3c58-77fd-45db-8412-22c61fc0493f 61 fields · synced Aug 4, 2026
- EUDAMED 08c6f4b2-f57b-4527-8ad7-278250e6f588 61 fields · synced Sep 17, 2026