Gebauer's Pain Ease Medium Stream

FDA UDI

Class U (US FDA UDI)

by Gebauer Co.

Identity

Trade Name: Gebauer's Pain Ease Medium Stream FDA UDI
Generic Name: Cold/cool therapy spray FDA UDI
Device Name: PE Med Topical Anesthetic Spray Single Patient, 30 mL FDA UDI
Model / Reference: 0386-0008-04 FDA UDI
Description: PE Med Topical Anesthetic Spray Single Patient, 30 mL FDA UDI

Identifiers

Catalog Number: 0386-0008-04 FDA UDI
Primary DI / UDI-DI: 00303860008040 FDA UDI
510(k) Number: K172028 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 30 Milliliter FDA UDI

Category: Cold/cool therapy spray

Gebauer's Pain Ease Medium Stream by Gebauer Co. — 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
CryoDose TA — NUANCE MEDICAL, LLC · U
Coolject Standard Nozzle Accessory — Vapocoolshot, Inc · U

Cleared under the same submission

K172028 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: Gebauer Co.

Sources (1)

FDA UDI 23721e87-be43-4ad4-a56f-f8d8cf11ca0f 38 fields · synced May 30, 2026