Identity
- Trade Name
- Green Guard Cold Spray FDA UDI
- Generic Name
- Cold/cool therapy spray FDA UDI
- Device Name
- A non-sterile liquid in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling. FDA UDI
- Model / Reference
- 3005 FDA UDI
- Description
- A non-sterile liquid in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling. FDA UDI
Identifiers
- Catalog Number
- 3005 FDA UDI
- Primary DI / UDI-DI
- 00347682030056 FDA UDI
- 510(k) Number
- K033720 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cold/cool therapy spray
Green Guard Cold Spray by Greenguard — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cold/cool therapy spray.
- CoolJect Targeted-Mist Topical Anesthetic — Vapocoolshot, Inc · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- CryoDose TA — NUANCE MEDICAL, LLC · U
- CoolJect Targeted-Mist Topical Anesthetic — Vapocoolshot, Inc · U
- CryoDose TA — NUANCE MEDICAL, LLC · U
- Coolject Topical Anesthetic Canister — Vapocoolshot, Inc · U
- Gebauer's Instant Ice — Gebauer Co. · U
- CryoDose TA — NUANCE MEDICAL, LLC · U
Cleared under the same submission
K033720 also covers:
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
- Greenguard
Sources (1)
- FDA UDI 2700f674-df5d-4b00-b43b-334d9fd1e112 37 fields · synced May 30, 2026