Identity
- Trade Name
- SCANLAN® Needle Holders FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® Valve Dilator EUDAMEDSCANLAN® Richards Micro Needle Holder EUDAMEDRichards Micro Needle Holder FDA UDI
- Model / Reference
- 3003-452 EUDAMEDFDA UDI
- Description
- Richards Micro Needle Holder FDA UDI
Identifiers
- Catalog Number
- 3003-452 FDA UDI
- Primary DI / UDI-DI
- 00846159003383 EUDAMEDFDA UDI00846159032017 EUDAMED
- Basic UDI-DI
- B-00846159032017 EUDAMEDB-00846159003383 EUDAMED
- FDA Product Code
- FHQ FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMEDL0205 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 (3)
- FDA UDI b76353f3-7faa-451e-916b-13535cb4f9ce 35 fields · synced Jun 19, 2026
- EUDAMED 84bec59b-9d2c-43aa-97b5-dd9d5b61883c 61 fields · synced Jun 14, 2026
- EUDAMED 95208d20-f02d-49f4-a513-2fd31bb2f64c 61 fields · synced Jun 19, 2026