Identity
- Trade Name
- ONETRAC FDA UDI
- Generic Name
- Hand-held surgical retractor, single-use FDA UDI
- Device Name
- ONETRAC Retractor 135mmx20mm with Built-In Single-Use Light Source - STERILE FDA UDI
- Model / Reference
- C100165 FDA UDI
- Description
- ONETRAC Retractor 135mmx20mm with Built-In Single-Use Light Source - STERILE FDA UDI
Identifiers
- Primary DI / UDI-DI
- M648C1001650 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Hand-held surgical retractor, single-use 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: Hand-held surgical retractor, single-use
Onetrac by Obp Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held surgical retractor, single-use.
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- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- SOAR Retractor System — SPINEOLOGY INC. · Class I
- SOAR Retractor System — SPINEOLOGY INC. · 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 6e191ee2-b828-4647-b2ef-1ab55fa59f29 33 fields · synced May 30, 2026