Identity
- Trade Name
- SCANLAN® Needle Holders FDA UDISCANLAN® MicroSurgical Instruments FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDINeurosurgical probe FDA UDI
- Device Name
- SCANLAN® Ochsner Doubled Ended Dissector EUDAMEDSCANLAN® Puskas™ Jacobson Micro Needle Holder EUDAMEDPuskas™ Jacobson Micro Needle Holder FDA UDIOchsner Double Ended Dissector FDA UDI
- Model / Reference
- 3003-383 EUDAMEDFDA UDI9009-146 FDA UDI
- Description
- Puskas™ Jacobson Micro Needle Holder FDA UDIOchsner Double Ended Dissector FDA UDI
Identifiers
- Catalog Number
- 3003-383 FDA UDI9009-146 FDA UDI
- Primary DI / UDI-DI
- 00846159019292 EUDAMEDFDA UDI00846159011043 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159011043 EUDAMEDB-00846159019292 EUDAMED
- FDA Product Code
- FHQ FDA UDIGZX FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMEDL0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDINeurosurgical probe FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 FDA UDI882.4525 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 (4)
- FDA UDI e951e3f0-4abb-4f89-82af-095de4948690 35 fields · synced Jul 31, 2026
- FDA UDI e8f7d1d5-b3fe-47c5-8d5a-80d4185fb627 35 fields · synced May 30, 2026
- EUDAMED 024b254e-12b4-4d52-9c12-1a227e09fb1f 61 fields · synced Jun 18, 2026
- EUDAMED 8079aee7-475a-4241-aa3f-09640271f6ee 61 fields · synced Jul 31, 2026