Identity
- Trade Name
- Reusable Ratchet Handle - tips 34cm each FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- Reusable Ratchet Handle - tips 34cm each FDA UDI
- Model / Reference
- OS3R FDA UDI
- Description
- Reusable Ratchet Handle - tips 34cm each FDA UDI
Identifiers
- Primary DI / UDI-DI
- B354OS3R4 FDA UDI
- 510(k) Number
- K101733 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Peracetic Acid FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusableEndoscopic electrosurgical electrode, monopolar, single-use
Reusable Ratchet Handle - tips 34cm each by Orange Surgical Instruments, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical electrode, monopolar, single-use.
- FlexTrode® Malleable Electrode — ELLIQUENCE LLC · Class II
- BOVIE — BOVIE MEDICAL CORPORATION · Class II
- USA Elite — Gyrus Acmi, Inc. · Class II
- CleanCoat — Covidien LP · Class II
- E-LINE — Richard Wolf GmbH · Class II
- Valleylab — Covidien LP · Class II
- Modulap — ATC TECHNOLOGIES INC. · Class II
- Bovie — BOVIE MEDICAL CORPORATION · 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 87ac2c23-3b8b-42a4-9b43-bf305a42373c 34 fields · synced May 31, 2026