Identity
- Trade Name
- LUKE BX Single Use Biopsy Forceps FDA UDI
- Generic Name
- Flexible endoscopic biopsy forceps, single-use FDA UDI
- Device Name
- Single-use Biopsy Forceps FDA UDI
- Model / Reference
- BFC-MD-000650 FDA UDI
- Description
- Single-use Biopsy Forceps FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810024670284 FDA UDI
- FDA Product Code
- FCL FDA UDI
- GMDN Term
- Flexible endoscopic biopsy forceps, single-use FDA UDI
Classification
- Device Class
- Class I 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible endoscopic biopsy forceps, single-use
LUKE BX Single Use Biopsy Forceps by CenterPoint Systems LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic biopsy forceps, single-use.
- Disposable Biopsy Forceps — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class IIa
- Single Use Biopsy Forceps — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class I
- Disposable Endoscopic Biopsy Forceps — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- POWER-ENDO — Jiangsu Power-endo Medical Technology Co., Ltd · Class IIa
- Single Use Biopsy Forceps — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Single-use Biopsy Forceps — Anrei Medical (HZ) CO., LTD. · Class IIa
- Disposable Biopsy Forceps — Jiangsu Ate Medical Technology Co., Ltd. · Class IIa
- Disposable Biopsy Forceps — Endoaccess GmbH · Class IIa
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
- CenterPoint Systems LLC
Sources (1)
- FDA UDI decb77f6-44b2-4697-9929-14e252b7891e 33 fields · synced Jun 9, 2026