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Hurri-Freeze 35mL Mist

by Beutlich Pharmaceuticals, LLC

Hurri-Freeze 35mL Mist is a cold/cool therapy spray (FDA unclassified; FDA product code MLY, Vapocoolant Device) made by Beutlich Pharmaceuticals, LLC, cleared under FDA 510(k) K232674 on 12 Feb 2024 and listed in FDA GUDID since 15 Dec 2025 (UDI-DI 10723797809447), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K232674

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10723797809447 UDI-DI Date15 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232674 Date12 Feb 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232674 decided 12 Feb 2024 Active
  • FDA GUDID UDI-DI 10723797809447 listed 15 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232674
  2. Listed FDA GUDID 10723797809447

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hurri-Freeze
Generic name
Cold/cool therapy spray
Model / reference
35mL Mist
Primary DI / UDI-DI
10723797809447
510(k) Number
FDA product code
MLY
GMDN term
Cold/cool therapy spray
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K232674)

and 1 more cleared under K232674

Similar devices

Other devices filed under FDA product code MLY (Vapocoolant Device).

Other devices from Beutlich Pharmaceuticals, LLC

See all devices from Beutlich Pharmaceuticals, LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)