Identity
- Trade Name
- MIRA Cryosurgical Probe, Hammerhead FDA UDI
- Generic Name
- Ophthalmic cryosurgical system, mechanical FDA UDI
- Device Name
- 6x2.8mm Curved Hammerhead Probe FDA UDI
- Model / Reference
- CR4075 FDA UDI
- Description
- 6x2.8mm Curved Hammerhead Probe FDA UDI
Identifiers
- Catalog Number
- CR4075 FDA UDI
- Primary DI / UDI-DI
- 10850510007559 FDA UDI
- 510(k) Number
- K760686 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Ophthalmic cryosurgical system, mechanical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic cryosurgical system, mechanical
MIRA Cryosurgical Probe, Hammerhead by Mira, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic cryosurgical system, mechanical.
- Ultimate Ice — Ultimate Dental · Class II
- MIRA Cryosurgical Console — MIRA, INC. · Class II
- MIRA Cryosurgical Probe, Abramson Retinoblastoma — MIRA, INC. · Class II
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- MIRA Cryosurgical Probe, Gaynon Curved Cataract — MIRA, INC. · Class II
- MIRA Cryosurgical Probe, Straight Mini Vitreous — MIRA, INC. · Class II
- MIRA Cryosurgical Probe, Curved Cataract — MIRA, INC. · Class II
Cleared under the same submission
K760686 also covers:
- MIRA Cryosurgical Console — MIRA, INC.
- MIRA Cryosurgical Probe, Abramson Retinoblastoma — MIRA, INC.
- MIRA Cryosurgical Probe, Baby Hammerhead — MIRA, INC.
- MIRA Cryosurgical Probe, Curved Cataract — MIRA, INC.
- MIRA Cryosurgical Probe, Curved Glaucoma — MIRA, INC.
- MIRA Cryosurgical Probe, Curved Retinal — MIRA, INC.
- MIRA Cryosurgical Probe, Gaynon Curved Cataract — MIRA, INC.
- MIRA Cryosurgical Probe, Mini Curved Cataract — MIRA, INC.
- MIRA Cryosurgical Probe, Straight Cataract — MIRA, INC.
- MIRA Cryosurgical Probe, Straight Mini Vitreous — MIRA, INC.
- MIRA Cryosurgical Probe, Straight Retinal — MIRA, INC.
- MIRA Cryosurgical Probe, Straight Vitreous — MIRA, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Mira, Inc.
Sources (1)
- FDA UDI 58522746-8732-4628-be5a-2904ac5094b0 36 fields · synced May 30, 2026