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AED FB3154 Flexible Biopsy Cup w/ Teeth Forcep, 1.6mm x 65cm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AED FB3154 Flexible Biopsy Cup w/ Teeth Forcep, 1.6mm x 65cm FDA UDI
- Generic Name
- Flexible endoscopic biopsy forceps, reusable FDA UDI
- Device Name
- It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. FDA UDI
- Model / Reference
- FB3154 FDA UDI
- Description
- It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. FDA UDI
Identifiers
- Catalog Number
- FB3154 FDA UDI
- Primary DI / UDI-DI
- 00848657074759 FDA UDI
- 510(k) Number
- K993689 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Flexible endoscopic biopsy 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Flexible endoscopic biopsy forceps, reusable
AED FB3154 Flexible Biopsy Cup w/ Teeth Forcep, 1.6mm x 65cm by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Flexible endoscopic biopsy forceps, reusable.
- Laryngoscopy Forceps — SONTEC INSTRUMENTS, INC. · Class I
- STRATTE SCISSORS — SONTEC INSTRUMENTS, INC. · Class I
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- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Laryngoscopy Forceps — SONTEC INSTRUMENTS, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
Cleared under the same submission
K993689 also covers:
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, 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
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI d00d78ba-4e4f-45b4-bf93-c8f3ca4936f1 36 fields · synced May 31, 2026