Identity
- Trade Name
- SCANLAN® Needle Holders FDA UDISCANLAN® MicroSurgical Instruments FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDIOpen-surgery dissector FDA UDI
- Device Name
- SCANLAN® Penfield Dissector EUDAMEDJacobson Micro Needle Holder Round Handle FDA UDIPennfield Dissect., Single End, Light Pattern, 3 mm blunt dissector, Slightly curved FDA UDI
- Model / Reference
- 3003-177 EUDAMEDFDA UDI3781-16 FDA UDI
- Description
- Jacobson Micro Needle Holder Round Handle FDA UDIPennfield Dissect., Single End, Light Pattern, 3 mm blunt dissector, Slightly curved FDA UDI
Identifiers
- Catalog Number
- 3003-177 FDA UDI3781-16 FDA UDI
- Primary DI / UDI-DI
- 00846159032666 EUDAMEDFDA UDI00846159002836 FDA UDI
- Basic UDI-DI
- B-00846159032666 EUDAMED
- FDA Product Code
- FHQ FDA UDIGDI FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDIOpen-surgery dissector FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 FDA UDI878.4800 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® 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 (3)
- FDA UDI 234f1c44-d023-4413-a36b-283c4c7458ca 35 fields · synced Jun 19, 2026
- FDA UDI ba5a4427-0d16-4ba4-ac13-69d5c4d6eae7 35 fields · synced May 30, 2026
- EUDAMED 40b05f46-21b7-4195-bbd3-44b2c55481a1 61 fields · synced Jun 19, 2026