AccessGUDID - DEVICE: Burkhart Polar Breeze Refrigerant Spray 6oz (00854212006561)

GUDID

Device Identifier (DI) Information

Brand Name: Burkhart Polar Breeze Refrigerant Spray 6oz
Version or Model: 72720585
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BURKHART DENTAL SUPPLY CO., THE

Primary DI Number: 00854212006561
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027532357 *Terms of Use

Device Description: No description.

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:	Yes
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?
38787	Cryogenic spray, dental	A liquid/gaseous refrigerant, typically contained in an aerosol or other spray dispenser, which is applied (sprayed) to a tooth to chill it, primarily to observe the patient's resulting intensity and duration of sensation in the evaluation of dental pulp vitality (i.e., helps to determine if the pulp is normal, inflamed, or necrotic). Some refrigerants may be used as a local anaesthetic when extracting deciduous teeth in children. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAT	Tester, Pulp

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K930764	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 33efff10-f4a8-4b6e-8997-afaeb47f6760
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016