Identity
- Trade Name
- SCANLAN® Needle Holders FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® LEGACY Jacobson Titanium Micro Needle Holder EUDAMEDLEGACY Jacobson Titanium Micro Needle Holder FDA UDI
- Model / Reference
- 3003-354 EUDAMEDFDA UDI
- Description
- LEGACY Jacobson Titanium Micro Needle Holder FDA UDI
Identifiers
- Catalog Number
- 3003-354 FDA UDI
- Primary DI / UDI-DI
- 00846159031607 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159031607 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® 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 (2)
- FDA UDI 791c1e99-783a-4dfa-b6b8-f015e0aef60d 35 fields · synced Jun 20, 2026
- EUDAMED f87ccc71-e60f-4c0f-825f-c9ce73d41dea 61 fields · synced Jun 20, 2026