Identity
- Trade Name
- Gebauer's Spray and Stretch FDA UDI
- Generic Name
- Cold/cool therapy spray FDA UDI
- Device Name
- SS Topical Anesthetic Spray FDA UDI
- Model / Reference
- 0386-0004-04 FDA UDI
- Description
- SS Topical Anesthetic Spray FDA UDI
Identifiers
- Catalog Number
- 0386-0004-04 FDA UDI
- Primary DI / UDI-DI
- 00303860004042 FDA UDI
- 510(k) Number
- K031036 FDA UDI
- FDA Product Code
- MLY FDA UDI
- GMDN Term
- Cold/cool therapy spray FDA UDI
Classification
- Device Class
- U 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 116 Milliliter FDA UDI
Category: Cold/cool therapy spray
Gebauer's Spray and Stretch by Gebauer Co. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cold/cool therapy spray.
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- CoolJect Targeted-Mist Topical Anesthetic — Vapocoolshot, Inc · U
- CryoDose TA — NUANCE MEDICAL, LLC · U
- Coolject Topical Anesthetic Canister — Vapocoolshot, Inc · U
- CryoDose TA — NUANCE MEDICAL, LLC · U
- Coolject Standard Nozzle Accessory — Vapocoolshot, Inc · U
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 U | Pending data |
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Manufacturer
- Manufacturer
- Gebauer Co.
Sources (1)
- FDA UDI 22d03b1e-378d-4009-be10-dd9fbb3b5b4d 38 fields · synced Jun 8, 2026