Identity
- Trade Name
- Wallach FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- Cone Cryosurgical Tip (T-0826) Sterilizable Cryotip FDA UDI
- Model / Reference
- 900206AA FDA UDI
- Description
- Cone Cryosurgical Tip (T-0826) Sterilizable Cryotip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937002720 FDA UDI
- 510(k) Number
- K803311 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
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
Wallach by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K803311 also covers:
- Wallach — CooperSurgical, Inc.
- Wallach — CooperSurgical, Inc.
- Wallach — CooperSurgical, Inc.
- Wallach — CooperSurgical, Inc.
- Wallach — CooperSurgical, Inc.
- Wallach — CooperSurgical, Inc.
- Wallach — CooperSurgical, Inc.
- Wallach — CooperSurgical, Inc.
- Wallach — CooperSurgical, Inc.
- Wallach — CooperSurgical, Inc.
- Wallach — CooperSurgical, Inc.
- Wallach — 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 |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI e7a15545-a36c-424b-8ee6-bd230a72cfaa 34 fields · synced Jun 9, 2026