Identity
- Trade Name
- GIGLI SAW BLADE HANDLE FDA UDI
- Generic Name
- Manual surgical saw, flexible FDA UDI
- Device Name
- GIGLI SAW BLADE HANDLE LOOP STYLE FDA UDI
- Model / Reference
- 1100-506 FDA UDI
- Description
- GIGLI SAW BLADE HANDLE LOOP STYLE FDA UDI
Identifiers
- Catalog Number
- 1100-506 FDA UDI
- Primary DI / UDI-DI
- 00192896081529 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual surgical saw, flexible
Gigli Saw Blade Handle by Sontec Instruments, Inc. — 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
- 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
- WIRE SAW — KLS-Martin L.P. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI eae7d5ef-5b09-4a11-9eb5-78e0d5db1266 35 fields · synced Jun 8, 2026