3 Ring Suture Passer - Kit Bariatric with 5mm and 10mm swabs
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 3 Ring Suture Passer - Kit Bariatric with 5mm and 10mm swabs FDA UDI
- Generic Name
- Laparoscopic wound closure thread FDA UDI
- Device Name
- 3 Ring Suture Passer - Kit Bariatric with 5mm and 10mm swabs FDA UDI
- Model / Reference
- OS3CDBKS FDA UDI
- Description
- 3 Ring Suture Passer - Kit Bariatric with 5mm and 10mm swabs FDA UDI
Identifiers
- Catalog Number
- OS3CDBKS FDA UDI
- Primary DI / UDI-DI
- B354OS3CDBKS0 FDA UDI
- 510(k) Number
- K101733 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusableEndoscopic electrosurgical electrode, monopolar, single-useInsufflation gas conditioning tubing setLaparoscopic wound closure thread
3 Ring Suture Passer - Kit Bariatric with 5mm and 10mm swabs by Orange Surgical Instruments, Llc — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K101733 also covers:
- 3 Ring Suture Passer — ORANGE SURGICAL INSTRUMENTS, LLC
- 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides — ORANGE SURGICAL INSTRUMENTS, LLC
- 5mm x 10mm Foam Sleeves — ORANGE SURGICAL INSTRUMENTS, LLC
- 5mm x 10mm Foam Sleeves — ORANGE SURGICAL INSTRUMENTS, LLC
- 8mm Plug x 3M Cable Disposable — ORANGE SURGICAL INSTRUMENTS, LLC
- Alligator Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC
- Alligator Padded Grasper — ORANGE SURGICAL INSTRUMENTS, LLC
- Alligator inner shaft 43cm — ORANGE SURGICAL INSTRUMENTS, LLC
- Allis Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC
- Allis Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC
- Atraumatic Fenestrated Grasper Tip — ORANGE SURGICAL INSTRUMENTS, LLC
- Babcock Forceps Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
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 036bc63e-4d25-4e4f-8bf1-8a7e08f6adc5 35 fields · synced Jun 6, 2026