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Grasper Atraumatic 34mm Blade Shaft insert 33cm Disposable
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Grasper Atraumatic 34mm Blade Shaft insert 33cm Disposable FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Grasper Atraumatic 34mm Blade Shaft insert 33cm Disposable FDA UDI
- Model / Reference
- OS335MG34I FDA UDI
- Description
- Grasper Atraumatic 34mm Blade Shaft insert 33cm Disposable FDA UDI
Identifiers
- Primary DI / UDI-DI
- B354OS335G34I0 FDA UDI
- 510(k) Number
- K101733 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use 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
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
Grasper Atraumatic 34mm Blade Shaft insert 33cm Disposable by Orange Surgical Instruments, Llc — Class II — FDA UDI — listed in FDA GUDID
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 0d15a50a-aee6-4f02-9224-b948fddb592f 35 fields · synced Jun 1, 2026