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3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides FDA UDI
- Generic Name
- Laparoscopic wound closure thread FDA UDI
- Device Name
- 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides FDA UDI
- Model / Reference
- OS3CDK15 FDA UDI
- Description
- 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides FDA UDI
Identifiers
- Catalog Number
- OS3CDK15 FDA UDI
- Primary DI / UDI-DI
- B354OS3CDK15 FDA UDI
- FDA Product Code
- GCJ FDA UDIHIF FDA UDIGEI FDA UDI
- GMDN Term
- Laparoscopic wound closure thread FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI884.1730 FDA UDI878.4400 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Endoscopic electrosurgical handpiece/electrode, monopolar, reusableInsufflation gas conditioning tubing setLaparoscopic wound closure threadCell morphology analyser IVD, automated/semi-automated
3 Ring Suture Passer Kit with 10/12mm and 15mm Guides by Orange Surgical Instruments, Llc — Class II — FDA UDI — listed in FDA GUDID
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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
- Orange Surgical Instruments, Llc
Sources (1)
- FDA UDI 9668bdf4-c165-4d3d-a789-61a470a18f9d 34 fields · synced May 30, 2026