Identity
- Trade Name
- Integra® Miltex® FDA UDI
- Generic Name
- Manual surgical saw, flexible FDA UDI
- Device Name
- Integra® Miltex® Gigli-Strully Saw Handle 3-1/2", Loop Style, with Snap-Lock FDA UDI
- Model / Reference
- MH26-124 FDA UDI
- Description
- Integra® Miltex® Gigli-Strully Saw Handle 3-1/2", Loop Style, with Snap-Lock FDA UDI
Identifiers
- Catalog Number
- MH26-124 FDA UDI
- Primary DI / UDI-DI
- 10381780445593 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
Moist Heat or Steam Sterilization FDA UDI
Category: Manual surgical saw, flexible
Integra® Miltex® by Integra LifeSciences Production Corporation — 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
- GIGLI SAW SOLID HANDLE — SONTEC INSTRUMENTS, INC. · Class I
- STILLE Various Instruments — Stille AB · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- WIRE SAW — KLS-Martin L.P. · Class I
- Gigli Saw Handle — N S SURGICAL COMPANY · Class I
- Quinelato — Schobell Industrial Ltda · 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
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 187046ba-b7b7-4e10-836a-d4a0a87d3ced 35 fields · synced Jun 9, 2026