Identity
- Trade Name
- Gigli Saw Handle FDA UDI
- Generic Name
- Manual surgical saw, flexible FDA UDI
- Device Name
- A hand-held manual surgical instrument typically used in orthopaedic or neurological surgery for cutting bone through a sawing action performed by the operator. It typically consists of an exchangeable, flexible, wire-like blade with a handle at each end of the blade. The handles can be easily unhooked to permit entry of the blade into a narrow opening, e.g., holes drilled in the top of the skull through which the flexible blade is fed for sawing of the skull prior to removal of the top section. This device is commonly known as a Gigli saw. This is a reusable device. FDA UDI
- Model / Reference
- 07-066-06 FDA UDI
- Description
- A hand-held manual surgical instrument typically used in orthopaedic or neurological surgery for cutting bone through a sawing action performed by the operator. It typically consists of an exchangeable, flexible, wire-like blade with a handle at each end of the blade. The handles can be easily unhooked to permit entry of the blade into a narrow opening, e.g., holes drilled in the top of the skull through which the flexible blade is fed for sawing of the skull prior to removal of the top section. This device is commonly known as a Gigli saw. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- 07-066-06 FDA UDI
- Primary DI / UDI-DI
- G25007066060 FDA UDI
- FDA Product Code
- GDR FDA UDI
- GMDN Term
- Manual surgical saw, flexible FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 9 Centimeter FDA UDI
Category: Manual surgical saw, flexible
Gigli Saw Handle by N S Surgical Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual surgical saw, flexible.
- SAW — KLS-Martin L.P. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Integra® Ruggles®-Redmond™ — Integra LifeSciences Production Corporation · Class I
- GIGLI SAW SOLID HANDLE — SONTEC INSTRUMENTS, INC. · Class I
- STILLE Various Instruments — Stille AB · Class I
- Integra® Ruggles®-Redmond™ — Integra LifeSciences Production Corporation · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Integra® Ruggles®-Redmond™ — Integra LifeSciences Production Corporation · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- N S Surgical Company
Sources (1)
- FDA UDI 4f875d42-2e3b-4512-abe5-4db6a2792e75 35 fields · synced May 30, 2026