Identity
- Trade Name
- SCANLAN® Needle Holders FDA UDISCANLAN® Minimally-Invasive Instrumentation FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDILung spatula FDA UDI
- Device Name
- SCANLAN® Periosteal Elevator EUDAMEDRyder Needle Holder Diamond Dust™ Jaw FDA UDIThorascopic Periosteal Elevator FDA UDI
- Model / Reference
- 3003-434 EUDAMEDFDA UDI9009-823-17 FDA UDI
- Description
- Ryder Needle Holder Diamond Dust™ Jaw FDA UDIThorascopic Periosteal Elevator FDA UDI
Identifiers
- Catalog Number
- 3003-434 FDA UDI9009-823-17 FDA UDI
- Primary DI / UDI-DI
- 00846159035179 EUDAMEDFDA UDI00846159003321 FDA UDI
- Basic UDI-DI
- B-00846159035179 EUDAMED
- FDA Product Code
- FHQ FDA UDIHTE FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDILung spatula 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 UDIFDA 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 0e791166-09f7-4175-990e-1f90773dd39c 35 fields · synced Jul 9, 2026
- FDA UDI 9d72775d-1bb3-4452-9cd4-1dafc7ff494d 35 fields · synced May 30, 2026
- EUDAMED 0bf177ca-18e1-4835-8d65-36387d0c59e1 61 fields · synced Jul 9, 2026