Gebauer's Spray and Stretch 0386-0004-04

GUDID 20303860004046

SS Topical Anesthetic Spray

GEBAUER COMPANY

Cold/cool therapy spray
Primary Device ID20303860004046
NIH Device Record Key22d03b1e-378d-4009-be10-dd9fbb3b5b4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGebauer's Spray and Stretch
Version Model Number0386-0004-04
Catalog Number0386-0004-04
Company DUNS004166021
Company NameGEBAUER COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-321-9348
Emailinformation@gebauer.com

Device Dimensions

Total Volume116 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100303860004042 [Primary]
GS120303860004046 [Package]
Contains: 00303860004042
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLYRefrigerant, Topical (Vapocoolant)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-06
Device Publish Date2020-02-27