Identity
- Trade Name
- SCANLAN® Minimally Invasive Instrument FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- Gonzalez-Rivas Segment Dissector FDA UDI
- Model / Reference
- 9009-219 FDA UDI
- Description
- Gonzalez-Rivas Segment Dissector FDA UDI
Identifiers
- Catalog Number
- 9009-219 FDA UDI
- Primary DI / UDI-DI
- 00846159036114 FDA UDI
- 510(k) Number
- K945474 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
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: Rigid endoscopic tissue manipulation forceps, reusable
SCANLAN® Minimally Invasive Instrument by Scanlan International Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rigid endoscopic tissue manipulation forceps, reusable.
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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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (1)
- FDA UDI b28b459f-a9bc-4ff9-b18d-951ddd314354 36 fields · synced Jun 6, 2026