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SCANLAN® Heavy Style Needle Holder
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 6006-612Ref 6006-610Ref 6006-620Ref 6006-632Ref 6006-630Ref 6006-622
Identity
- Trade Name
- SCANLAN® Heavy Style Needle Holder FDA UDISCANLAN® Heavy Style Needle Holders FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® Heavy Style Needle Holders EUDAMEDDiamond Dust™jaw FDA UDIDiamond Dust™ Jaw FDA UDICurved Diamond Dust™jaw FDA UDI
- Model / Reference
- 6006-630 EUDAMEDFDA UDI6006-632 EUDAMEDFDA UDI6006-610 EUDAMEDFDA UDI6006-612 EUDAMEDFDA UDI6006-622 EUDAMEDFDA UDI6006-620 EUDAMEDFDA UDI6006-606 FDA UDI
- Description
- Diamond Dust™jaw FDA UDIDiamond Dust™ Jaw FDA UDICurved Diamond Dust™jaw FDA UDI
Identifiers
- Catalog Number
- 6006-630 FDA UDI6006-606 FDA UDI6006-632 FDA UDI6006-610 FDA UDI6006-612 FDA UDI6006-622 FDA UDI6006-620 FDA UDI
- Primary DI / UDI-DI
- 00846159005080 EUDAMEDFDA UDI00846159027037 EUDAMEDFDA UDI00846159005066 EUDAMEDFDA UDI00846159027013 EUDAMEDFDA UDI00846159027020 EUDAMEDFDA UDI00846159005073 EUDAMEDFDA UDI00846159031751 FDA UDI
- Basic UDI-DI
- B-00846159027013 EUDAMEDB-00846159005066 EUDAMEDB-00846159005073 EUDAMEDB-00846159027037 EUDAMEDB-00846159005080 EUDAMEDB-00846159027020 EUDAMED
- FDA Product Code
- FHQ FDA UDI
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 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 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® Heavy Style Needle Holder 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 (13)
- FDA UDI 9edba1b4-7691-4fe0-bbdf-487602c27885 35 fields · synced Oct 6, 2026
- FDA UDI 9fa5773d-b01c-4e4c-8895-813264fd6c8e 35 fields · synced May 29, 2026
- FDA UDI d150316c-b414-4e99-887a-6c84342b3508 35 fields · synced May 30, 2026
- FDA UDI a7636ce7-4cf7-4b85-8caa-68e785cd9df3 35 fields · synced May 30, 2026
- FDA UDI 54fbc961-af75-457b-9667-a6924acd1a1c 35 fields · synced May 30, 2026
- FDA UDI c3b13efe-7b2d-4626-9fed-1bf1fe03e9a2 35 fields · synced May 30, 2026
- FDA UDI f3fd5f77-3a10-4b97-838a-23b394a7f083 35 fields · synced May 30, 2026
- EUDAMED ebbf2f72-930a-4388-9dbd-29adb92e96ef 61 fields · synced Jul 11, 2026
- EUDAMED 80df5117-6823-436e-90f6-4d43f558c9d3 61 fields · synced Jul 12, 2026
- EUDAMED 01581bd0-a856-41c0-bc45-a4c4faa3be84 61 fields · synced Jul 15, 2026
- EUDAMED e5870a88-3b94-4c8b-853d-c6613026e13a 61 fields · synced Jul 18, 2026
- EUDAMED d608e9f0-7014-4352-8f61-34a07c76d070 61 fields · synced Jul 21, 2026
- EUDAMED 7454443b-7553-47a7-9583-0ff02aa45548 61 fields · synced Jul 25, 2026