Identity
- Trade Name
- Intacs for Keratoconus, Symmetric 0.210 mm FDA UDI
- Generic Name
- Intracorneal ring segment FDA UDI
- Device Name
- Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm. FDA UDI
- Model / Reference
- ICI-210-150 FDA UDI
- Description
- Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm. FDA UDI
Identifiers
- Catalog Number
- 11600-210-150 FDA UDI
- Primary DI / UDI-DI
- 00850048576100 FDA UDI
- PMA Number
- H040002 FDA UDI
- FDA Product Code
- LQE FDA UDI
- GMDN Term
- Intracorneal ring segment FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intracorneal ringIntracorneal ring segment
Intacs for Keratoconus, Symmetric 0.210 mm by Addition Technology — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracorneal ring.
- Intacs for Keratoconus, Symmetric 0.250 mm — Addition Technology · Class III
- Intacs for Myopia, Symmetric 0.350 mm — Addition Technology · Class III
- Intacs for Keratoconus, Symmetric 0.300 mm — Addition Technology · Class III
- Intacs for Keratoconus, Asymmetric 0.210/0.400 mm — Addition Technology · Class III
- Intacs for Keratoconus, Symmetric 0.350 mm — Addition Technology · Class III
- Intacs for Myopia, Symmetric 0.300 mm — Addition Technology · Class III
- Intacs for Keratoconus, Symmetric 0.450 mm — Addition Technology · Class III
- Intacs for Keratoconus, Asymmetric 0.210/0.450 mm — Addition Technology · Class III
Cleared under the same submission
H040002 also covers:
- Intacs for Keratoconus, Asymmetric 0.210/0.350 mm — Addition Technology
- Intacs for Keratoconus, Asymmetric 0.210/0.400 mm — Addition Technology
- Intacs for Keratoconus, Asymmetric 0.210/0.450 mm — Addition Technology
- Intacs for Keratoconus, Symmetric 0.250 mm — Addition Technology
- Intacs for Keratoconus, Symmetric 0.300 mm — Addition Technology
- Intacs for Keratoconus, Symmetric 0.350 mm — Addition Technology
- Intacs for Keratoconus, Symmetric 0.400 mm — Addition Technology
- Intacs for Keratoconus, Symmetric 0.450 mm — Addition Technology
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 III | Pending data |
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Manufacturer
- Manufacturer
- Addition Technology
Sources (1)
- FDA UDI b52aced2-ef6a-4838-ab88-ff7a04995ebd 35 fields · synced Jun 1, 2026