Identity
- Trade Name
- LAP-13-4 FDA UDI
- Generic Name
- ERCP catheter, non-balloon, non-electrical, single-use FDA UDI
- Device Name
- Cholangiography Catheter, Port Insertion FDA UDI
- Model / Reference
- D1005 FDA UDI
- Description
- Cholangiography Catheter, Port Insertion FDA UDI
Identifiers
- Catalog Number
- D1005 FDA UDI
- Primary DI / UDI-DI
- 00842102105081 FDA UDI
- FDA Product Code
- GBZ FDA UDI
- GMDN Term
- ERCP catheter, non-balloon, non-electrical, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
No
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
No
FDA UDI
Category: ERCP catheter, non-balloon, non-electrical, single-use
Lap-13-4 by Flexbar Machine Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ERCP catheter, non-balloon, non-electrical, single-use.
- Olsen — COOK INCORPORATED · Class I
- Reddick Cholangiogram Catheter — LeMaitre Vascular, Inc. · Class I
- EXAMINE — Conmed Corporation · Class II
- Single Use Cannula V — Olympus Medical Systems Corporation · Class II
- Cook — COOK INCORPORATED · Class II
- Single Use 2-Lumen Cannula V — Olympus Medical Systems Corporation · Class II
- Olsen — COOK INCORPORATED · Class I
- Single Use Cannula V — Olympus Medical Systems Corporation · Class II
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
- Flexbar Machine Corp.
Sources (1)
- FDA UDI d7c1d5ac-2a00-4f18-98c7-b37aee49883c 34 fields · synced Jun 6, 2026