Identity
- Trade Name
- SCANLAN® FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- SCANLAN® CardioVasive™ Jacobson Needle Holder EUDAMEDJacobson Needle Holder with Ratchet, fine jaw FDA UDI
- Model / Reference
- 9009-648-12 EUDAMEDFDA UDI
- Description
- Jacobson Needle Holder with Ratchet, fine jaw FDA UDI
Identifiers
- Catalog Number
- 9009-648-12 FDA UDI
- Primary DI / UDI-DI
- 00846159030198 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159030198 EUDAMED
- 510(k) Number
- K945474 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Rigid endoscopic tissue manipulation forceps, reusable
Scanlan® by Scanlan International Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K945474 also covers:
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI 48df0ba2-9097-40fa-91b7-e4efd3e4b00a 36 fields · synced Jul 10, 2026
- EUDAMED fc07ac5f-d738-4258-9857-e6e42431bc26 61 fields · synced Jul 10, 2026