Identity
- Trade Name
- Endodrill Biopsy instrument FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- Sterile single use EndoDrill® GI Biopsy Instrument to be used with Endodrill® Drive system. The EndoDrill® is a surgical instrument intended to collect tissue for histological examination through a flexible endoscope. Shipment box of 5 in catalogue number 13002 FDA UDI
- Model / Reference
- GI 17G FDA UDI
- Description
- Sterile single use EndoDrill® GI Biopsy Instrument to be used with Endodrill® Drive system. The EndoDrill® is a surgical instrument intended to collect tissue for histological examination through a flexible endoscope. Shipment box of 5 in catalogue number 13002 FDA UDI
Identifiers
- Catalog Number
- 13002 FDA UDI
- Primary DI / UDI-DI
- 37340179900058 FDA UDI
- 510(k) Number
- K212423 FDA UDI
- FDA Product Code
- FCG FDA UDI
- GMDN Term
- General-purpose endoscopic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose endoscopic needle, single-use
Endodrill Biopsy instrument by Bibbinstruments AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212423 also covers:
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
- Bibbinstruments AB
Sources (1)
- FDA UDI 8f62f276-4f18-4b11-86bd-62f8da415ef1 35 fields · synced May 30, 2026