Identity
- Trade Name
- Nylon Extra Large Retrieval Pouch FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Nylon Extra Large Retrieval Pouch FDA UDI
- Model / Reference
- OS811RP FDA UDI
- Description
- Nylon Extra Large Retrieval Pouch FDA UDI
Identifiers
- Catalog Number
- OS811RP FDA UDI
- Primary DI / UDI-DI
- B354OS811RP0 FDA UDI
- 510(k) Number
- K101733 FDA UDI
- FDA Product Code
- GEI FDA UDIGCJ FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI876.1500 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
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 electrode, monopolar, single-useTissue extraction bag
Nylon Extra Large Retrieval Pouch by Orange Surgical Instruments, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue extraction bag.
- Alexis® Contained Extraction System — APPLIED MEDICAL RESOURCES CORP. · Class II
- SimplyStrong — Genicon · Class II
- DR. POYNTER MC — APPLIED MEDICAL RESOURCES CORP. · Class II
- DR.BRIZENDINE LAP CHOLECYSTECTOMY — APPLIED MEDICAL RESOURCES CORP. · Class I
- GeniStrong — Genicon · Class II
- TOTAL 5mm SOLUTION KIT 11 — APPLIED MEDICAL RESOURCES CORP. · Class II
- PARTNERS LC KIT 006 — APPLIED MEDICAL RESOURCES CORP. · Class II
- DR. FILLMORE LAP CHOLE KIT — APPLIED MEDICAL RESOURCES CORP. · Class II
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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orange Surgical Instruments, Llc
Sources (1)
- FDA UDI 2d036afd-95bc-4090-a5f6-01cc0d2f540e 35 fields · synced May 30, 2026