Identity
- Trade Name
- Intacs Symmetric Glide FDA UDI
- Generic Name
- General-purpose surgical spatula FDA UDI
- Device Name
- The Symmetric Glide is a bifurcated glide instrument that is manufactured from surgical titanium and is inserted into the 1.2 mm entry incision to effectively guide the CW and CCW Corneal Separators into the stromal pocket. FDA UDI
- Model / Reference
- KV1160 FDA UDI
- Description
- The Symmetric Glide is a bifurcated glide instrument that is manufactured from surgical titanium and is inserted into the 1.2 mm entry incision to effectively guide the CW and CCW Corneal Separators into the stromal pocket. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850048576070 FDA UDI
- FDA Product Code
- HND FDA UDI
- GMDN Term
- General-purpose surgical spatula FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General-purpose surgical spatula
Intacs Symmetric Glide by Addition Technology — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Addition Technology
Sources (1)
- FDA UDI a2ac067c-b6c3-443a-b653-a4987c9863c7 33 fields · synced May 30, 2026