Identity
- Trade Name
- Integra® Miltex® FDA UDI
- Generic Name
- Gallstone scoop FDA UDI
- Device Name
- Integra® Miltex® Volkmann Scoop 8-3/4", Double-ended, 4mm x 7mm and 6mm x 12mm FDA UDI
- Model / Reference
- PM-1476B FDA UDI
- Description
- Integra® Miltex® Volkmann Scoop 8-3/4", Double-ended, 4mm x 7mm and 6mm x 12mm FDA UDI
Identifiers
- Catalog Number
- PM-1476B FDA UDI
- Primary DI / UDI-DI
- 10381780451907 FDA UDI
- FDA Product Code
- FHL FDA UDI
- GMDN Term
- Gallstone scoop FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
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: Gallstone scoop
Integra® Miltex® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gallstone scoop.
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- GEN2 — SURGIX MEDICAL LLC · Class II
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- Gimmi — Gimmi GmbH · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Sklar — Sklar Corporation · Class I
- Gimmi — Gimmi GmbH · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI c2f84b32-82a3-4de9-aeee-11105dec11d9 35 fields · synced Jun 9, 2026