AccessGUDID - DEVICE: Max Pro Medical Freeze Spray (00860177000636)

GUDID

Device Identifier (DI) Information

Brand Name: Max Pro Medical Freeze Spray
Version or Model: MPMF-6567
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ECOTEC MANUFACTURING, INC.

Primary DI Number: 00860177000636
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121411859 *Terms of Use

Device Description: Medical Freeze Spray

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):	No
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?
63529	Cryogenic tissue spray IVD	A refrigerant (e.g., tetrafluoroethane) in a spray container intended to be used for the rapid freezing of a tissue biopsy or cytology specimen, to facilitate sectioning with a cryotome for subsequent in vitro diagnostic analysis. It is not intended to be used as a tissue fixative. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IFI	Sprays, Synthetic, Smear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: e25a9c07-a77c-4392-966c-3fb877913466
Public Version Date: September 17, 2018
Public Version Number: 1
DI Record Publish Date: August 15, 2018