Identity
- Trade Name
- CooperSurgical, Inc. FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- 14 Gauge Tip, 3" Needle, Curved, Long FDA UDI
- Model / Reference
- 900104 FDA UDI
- Description
- 14 Gauge Tip, 3" Needle, Curved, Long FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937009996 FDA UDI
- 510(k) Number
- K935010 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General cryosurgical system, cryogen gas, mechanical
CooperSurgical, Inc. by CooperSurgical, Inc. — 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
- CryoProbe™ — H & O Equipments SA · Class II
- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
- Cardioblate® CryoFlex® — MEDTRONIC, INC. · Class II
- AtriCure cryoICE Cryoablation System (CRYO3) — ATRICURE, INC. · Class II
- truFreeze — US Endoscopy · Class II
- CVS Skin Tag Remover — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II
Cleared under the same submission
K935010 also covers:
- CooperSurgical, Inc. — CooperSurgical, Inc.
- CooperSurgical, Inc. — CooperSurgical, Inc.
- CooperSurgical, Inc. — CooperSurgical, Inc.
- WALLACH Cryosurgical Equipment — CooperSurgical, Inc.
- Wallach Ultra Freeze — CooperSurgical, Inc.
- Wallach UltraFreeze — CooperSurgical, Inc.
- Wallach UltraFreeze — CooperSurgical, Inc.
- Wallach UltraFreeze — CooperSurgical, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI dd08858a-6ac4-407b-8f18-2938608373f8 34 fields · synced Jun 9, 2026