AccessGUDID - DEVICE: Gebauer's Pain Ease Mist Spray (00303860008019)

GUDID

Device Identifier (DI) Information

Brand Name: Gebauer's Pain Ease Mist Spray
Version or Model: 0386-0008-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0386-0008-01
Company Name: GEBAUER COMPANY

Primary DI Number: 00303860008019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004166021 *Terms of Use

Device Description: PE Mist Topical Anesthetic Spray Single Patient, 30 mL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46557	Cold/cool therapy spray	A non-sterile liquid (e.g., alcohol based) 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 typically from sports injuries (cold therapy), and/or for cooling at the skin surface to treat heat rash or hot flushes (cool therapy); it may be intended to be applied to the skin directly or used in combination with a moist-cold pack/bandage (i.e., used to soak the moist-cold pack/bandage). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLY	Refrigerant, Topical (Vapocoolant)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172028	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 120 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 30 Milliliter

Device Record Status

Public Device Record Key: dafa4103-51e2-4596-897c-c82db6c6c5b4
Public Version Date: March 06, 2020
Public Version Number: 1
DI Record Publish Date: February 27, 2020