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SCANLAN® Needle Holders
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 3003-544Ref 3003-554Ref 3003-580Ref 3003-582Ref Q-2567-6Ref 9009-650-9Ref 3003-552Ref 3003-540-12Ref 3003-510Ref 3003-550Ref 3003-584Ref 3003-532Ref 3003-536Ref 3003-514Ref 3303-644Ref Q2140-3Ref 3003-546
Identity
- Trade Name
- SCANLAN® Needle Holders FDA UDISCANLAN® Titanium Needle Holder FDA UDISCANLAN® Jacobson Needle Holder FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® Jacobson Needle Holder EUDAMEDSCANLAN® CardioVasive™ Jacobson Needle Holder EUDAMEDJacobson Needle Holder FDA UDIJacobson Needle Holder, Ti JHSNH, RD, STL D-D J 12"/30.5cm FDA UDISCANLAN® CardioVasive™ Jacobson Needle Holder (5mm), Round Handle, Diamond Dust™ jaw with Ratchet, Curved Left, (1 cm jaw length; 6.5 cm working length), 9" / 23 cm FDA UDI
- Model / Reference
- 3003-536 EUDAMEDFDA UDI3003-540-12 EUDAMEDFDA UDI3003-584 EUDAMEDFDA UDI3003-552 EUDAMEDFDA UDI3003-514 EUDAMEDFDA UDI9009-650-9 EUDAMEDFDA UDI3003-510 EUDAMEDFDA UDI3003-532 EUDAMEDFDA UDI3003-580 EUDAMEDFDA UDI3003-554 EUDAMEDFDA UDI3003-550 EUDAMEDFDA UDI3003-546 EUDAMEDFDA UDI3003-544 EUDAMEDFDA UDI3003-582 EUDAMEDFDA UDIQ-2567-6 EUDAMED3303-644 EUDAMEDQ2140-3 EUDAMED
- Description
- Jacobson Needle Holder FDA UDIJacobson Needle Holder, Ti JHSNH, RD, STL D-D J 12"/30.5cm FDA UDISCANLAN® CardioVasive™ Jacobson Needle Holder (5mm), Round Handle, Diamond Dust™ jaw with Ratchet, Curved Left, (1 cm jaw length; 6.5 cm working length), 9" / 23 cm FDA UDI
Identifiers
- Catalog Number
- 3003-536 FDA UDI3003-540-12 FDA UDI3003-584 FDA UDI3003-552 FDA UDI3003-514 FDA UDI9009-650-9 FDA UDI3003-510 FDA UDI3003-532 FDA UDI3003-580 FDA UDI3003-554 FDA UDI3003-550 FDA UDI3003-546 FDA UDI3003-544 FDA UDI3003-582 FDA UDI
- Primary DI / UDI-DI
- 00846159022827 EUDAMEDFDA UDI00846159033069 EUDAMEDFDA UDI00846159026702 EUDAMEDFDA UDI00846159026641 EUDAMEDFDA UDI00846159019414 EUDAMEDFDA UDI00846159030242 EUDAMEDFDA UDI00846159003437 EUDAMEDFDA UDI00846159019438 EUDAMEDFDA UDI00846159003482 EUDAMEDFDA UDI00846159026658 EUDAMEDFDA UDI00846159003468 EUDAMEDFDA UDI00846159026634 EUDAMEDFDA UDI00846159019469 EUDAMEDFDA UDI00846159026696 EUDAMEDFDA UDI00846159036985 EUDAMED00846159036633 EUDAMED00846159036916 EUDAMED
- Basic UDI-DI
- B-00846159019469 EUDAMEDB-00846159026658 EUDAMEDB-00846159003482 EUDAMEDB-00846159026696 EUDAMEDB-00846159036985 EUDAMEDB-00846159030242 EUDAMEDB-00846159026641 EUDAMEDB-00846159033069 EUDAMEDB-00846159003437 EUDAMEDB-00846159003468 EUDAMEDB-00846159026702 EUDAMEDB-00846159019438 EUDAMEDB-00846159022827 EUDAMEDB-00846159019414 EUDAMEDB-00846159036633 EUDAMEDB-00846159036916 EUDAMEDB-00846159026634 EUDAMED
- 510(k) Number
- K945474 FDA UDI
- FDA Product Code
- FHQ FDA UDIGCJ FDA UDI
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 876.4730 FDA UDI876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
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 UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suturing needle holder, reusable
SCANLAN® Needle Holders by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (31)
- FDA UDI d301f5bb-1171-4314-a82c-e12f0e3f0331 35 fields · synced Aug 3, 2026
- FDA UDI 8ca3d306-b452-40a1-9b0d-0f6a4e5e450b 35 fields · synced May 24, 2026
- FDA UDI cd166408-50b4-48bb-8619-fbf75cece1e1 35 fields · synced May 25, 2026
- FDA UDI e93bd5fb-ccf6-4190-8898-f9e0b9a865b1 35 fields · synced May 30, 2026
- FDA UDI f3eba81d-9f71-4281-8a21-96bea9336b19 35 fields · synced May 30, 2026
- FDA UDI 948edb6c-1961-4323-a378-2da8a72b7322 36 fields · synced May 30, 2026
- FDA UDI f6ef1ab4-8259-4c95-920f-443200c9a97c 35 fields · synced May 30, 2026
- FDA UDI 1517f299-5057-43fc-9212-6dc9c52b1760 35 fields · synced May 30, 2026
- FDA UDI 9ff17567-8c9a-4c83-87fe-b2e0f0d0eaae 35 fields · synced May 30, 2026
- FDA UDI 5e6ec8a0-e8a9-43ac-8eab-dca85ce04697 35 fields · synced May 30, 2026
- FDA UDI def38ba8-2bc2-422b-a252-532ede9aa27a 35 fields · synced May 30, 2026
- FDA UDI 77a1ef9e-c6f2-44a9-8362-6ede27ead255 35 fields · synced May 30, 2026
- FDA UDI ab87da62-94f2-45d3-982d-2719671a7efa 35 fields · synced May 30, 2026
- FDA UDI 7b3c9a01-139b-4dbc-95a7-dd1aebfadb67 35 fields · synced May 30, 2026
- EUDAMED 7df79f69-bd1e-4b24-96d1-57a7f7d3e160 61 fields · synced Jun 20, 2026
- EUDAMED cdbb3b0e-f145-4949-89ad-c4474210a194 61 fields · synced Jul 9, 2026
- EUDAMED 81e6ee6b-0c69-4cab-93ce-e19bdf7000ed 61 fields · synced Jul 9, 2026
- EUDAMED fc8b11fd-acb1-4083-ae9b-58fa9dc58ada 61 fields · synced Jul 10, 2026
- EUDAMED 23e843ef-79c4-4a4b-8348-3bdafa7b57c6 61 fields · synced Jul 10, 2026
- EUDAMED 7302f6b1-b3f0-4592-87da-aaf71bb34cc4 61 fields · synced Jul 11, 2026
- EUDAMED a38502d6-6f8d-473d-8104-1d8921da98f3 61 fields · synced Jul 12, 2026
- EUDAMED 0fa0c23f-4e97-4c6f-8c79-7fcebe37351c 61 fields · synced Jul 13, 2026
- EUDAMED 9be8facf-f933-46ba-904f-915c0f7ed800 61 fields · synced Jul 13, 2026
- EUDAMED 0124d7dd-bc2a-428f-a3f3-97fee2ea5820 61 fields · synced Jul 13, 2026
- EUDAMED 243e4609-b9b7-44b9-9d8e-567434cc50e3 61 fields · synced Jul 19, 2026
- EUDAMED e2899f5e-d52f-4f45-8a89-6bdd135fdf49 61 fields · synced Jul 23, 2026
- EUDAMED 9a8c29d0-b46e-4b53-aa90-e4508cb52098 61 fields · synced Jul 24, 2026
- EUDAMED 61959615-46e4-444e-9cae-d3da3bb6e38f 61 fields · synced Jul 28, 2026
- EUDAMED eb282eef-325b-4b47-b4cf-b8fa78d810c0 61 fields · synced Jul 30, 2026
- EUDAMED 8fb93cdd-5c5e-4129-b114-c1f2db117f59 61 fields · synced Aug 3, 2026
- EUDAMED d9a2d5a3-04a1-4643-8b56-db89e6ae30a9 61 fields · synced Aug 3, 2026