Identity
- Trade Name
- Integra® Miltex® FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- Integra® Miltex® CryoSolutions® Complete Set, 1mm Standard Tip(33511), 1 Cartridge(33518)(23.5g N2O) and 1 Metal Pin(33520) FDA UDI
- Model / Reference
- 33510 FDA UDI
- Description
- Integra® Miltex® CryoSolutions® Complete Set, 1mm Standard Tip(33511), 1 Cartridge(33518)(23.5g N2O) and 1 Metal Pin(33520) FDA UDI
Identifiers
- Catalog Number
- 33510 FDA UDI
- Primary DI / UDI-DI
- 10381780171898 FDA UDI
- 510(k) Number
- K091721 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- General cryosurgical system, cryogen gas, 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General cryosurgical system, cryogen gas, mechanical
Integra® Miltex® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General cryosurgical system, cryogen gas, mechanical.
- AtriCure cryoICE cryoSPHERE Cryoablation System — ATRICURE, INC. · Class II
- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
- Frigitronics — CooperSurgical, Inc. · Class II
- CryoProbe™ — H & O Equipments SA · Class II
- Frigitronics — CooperSurgical, Inc. · Class II
- Wallach — CooperSurgical, Inc. · Class II
- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
Cleared under the same submission
K091721 also covers:
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI a501196f-88ab-4163-890a-3c49a13f2241 37 fields · synced Jun 9, 2026