Identity
- Trade Name
- Hrt38 -0- Bl Ppn 30"/75 Cm FDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
- Device Name
- Hrt38 -0- Bl Ppn 30"/75 Cm FDA UDI
- Model / Reference
- JC-1313N FDA UDI
- Description
- Hrt38 -0- Bl Ppn 30"/75 Cm FDA UDI
Identifiers
- Catalog Number
- JC-1313 FDA UDI
- Primary DI / UDI-DI
- 00848782017300 FDA UDI
- FDA Product Code
- GAW FDA UDI
- GMDN Term
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyolefin/fluoropolymer suture, monofilament
Hrt38 -0- Bl Ppn 30"/75 Cm by Surgical Specialties México, S. de R.L. de C.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polyolefin/fluoropolymer suture, monofilament.
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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
- Surgical Specialties México, S. de R.L. de C.V.
Sources (1)
- FDA UDI c171e73f-cb6e-48d5-8bb4-c67824be0f28 36 fields · synced May 31, 2026