Identity
- Trade Name
- Intacs Vacuum Centering Guide FDA UDI
- Generic Name
- Eyeball fixation instrument, reusable FDA UDI
- Device Name
- The Vacuum Centering Guide (VCG) is composed of stainless steel and features a port for attachment to a vacuum source (KV2000 Vacuum System). The VCG functions as a suction ring that is equipped with fins on the bottom to provide for rotational stability and a seating surface for adherence to and stabilization of the eye during the creation of the intrastromal tunnels. The VCG is contoured to allow for a more natural fit under the eye lids and the speculum. FDA UDI
- Model / Reference
- KV10478-2 FDA UDI
- Description
- The Vacuum Centering Guide (VCG) is composed of stainless steel and features a port for attachment to a vacuum source (KV2000 Vacuum System). The VCG functions as a suction ring that is equipped with fins on the bottom to provide for rotational stability and a seating surface for adherence to and stabilization of the eye during the creation of the intrastromal tunnels. The VCG is contoured to allow for a more natural fit under the eye lids and the speculum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850048576056 FDA UDI
- FDA Product Code
- HNH FDA UDI
- GMDN Term
- Eyeball fixation instrument, reusable 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: Eyeball fixation instrument, reusable
Intacs Vacuum Centering Guide by Addition Technology — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eyeball fixation instrument, reusable.
- Flieringa Scleral Fixation Ring, 13mm — KATALYST SURGICAL, LLC · Class I
- Walcott Rx Products — Walcott Rx Product Inc · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Rumex — Rumex International Co. · Class I
- Flieringa Scleral Fixation Ring, 17mm Diameter — AURORA SURGICAL, LLC · Class I
- FINE-THORNTON FIXATION RING 13MM — Katena Products, Inc. · Class I
- Flieringa Scleral Fixation Ring, 24mm — KATALYST SURGICAL, LLC · Class I
- TWIST HOOK RIGHT — Katena Products, Inc. · 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
- Addition Technology
Sources (1)
- FDA UDI 89a3b8cb-720c-4011-90d1-9863cb1b8a26 33 fields · synced Jun 1, 2026