Identity
- Trade Name
- ONETRAC FDA UDI
- Generic Name
- Abdominal retractor, hand-held FDA UDI
- Device Name
- C100150 ONETRAC Retractor 40x20mm with Built-In Single-Use Light Source - STERILE FDA UDI
- Model / Reference
- C100150 FDA UDI
- Description
- C100150 ONETRAC Retractor 40x20mm with Built-In Single-Use Light Source - STERILE FDA UDI
Identifiers
- Catalog Number
- C100150 FDA UDI
- Primary DI / UDI-DI
- M648C1001500 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Abdominal retractor, hand-held FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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: Abdominal retractor, hand-held
Onetrac by Obp Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Abdominal retractor, hand-held.
- traxi® Panniculus Retractor — Clinical Innovations, LLC · Class I
- Pilling — TELEFLEX INCORPORATED · Class I
- Reddick-Saye Screw Retractor — LeMaitre Vascular, Inc. · Class I
- traxi® Panniculus Retractor Extender — Clinical Innovations, LLC · Class I
- Pilling — TELEFLEX INCORPORATED · Class I
- ONETRAC — OBP CORPORATION · Class I
- ONETRAC — OBP CORPORATION · 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
- Obp Corporation
Sources (1)
- FDA UDI b50a6897-551d-4441-aa07-1392438d1492 35 fields · synced May 30, 2026