Identity
- Trade Name
- Dissecting Forceps (curved), Maryland FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- Dissecting Forceps (curved), Maryland FDA UDI
- Model / Reference
- OS5D6503C FDA UDI
- Description
- Dissecting Forceps (curved), Maryland FDA UDI
Identifiers
- Primary DI / UDI-DI
- B354OS5D6503C0 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
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Peracetic Acid FDA UDI
Dissecting Forceps (curved), Maryland by Orange Surgical Instruments, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Orange Surgical Instruments, Llc
Sources (1)
- FDA UDI 1e544d1d-f748-42d9-8ae6-4a0f63d70193 35 fields · synced Jun 1, 2026