Identity
- Trade Name
- SCANLAN® Needle Holders FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® Finesse Micro Needle Holder EUDAMEDFinesse Micro Needle Holder Round Handle FDA UDI
- Model / Reference
- 2926-00 EUDAMEDFDA UDI
- Description
- Finesse Micro Needle Holder Round Handle FDA UDI
Identifiers
- Catalog Number
- 2926-00 FDA UDI
- Primary DI / UDI-DI
- 00846159031553 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159031553 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
Similar devices
Also classified as Suturing needle holder, reusable.
- JACOBSON NEEDLE HOLDER — SONTEC INSTRUMENTS, INC. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- HNM Medical — HNM STAINLESS, LLC. · Class I
- PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI 0ddc79b3-aea3-46b1-b5ee-201d28ffd170 35 fields · synced Jun 18, 2026
- EUDAMED 0e29d0ad-1737-42c0-8341-4054bf23d6fc 61 fields · synced Jun 18, 2026