AccessGUDID - DEVICE: CryoDose TA (00856331006163)

GUDID

Device Identifier (DI) Information

Brand Name: CryoDose TA
Version or Model: 1804
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1804
Company Name: NUANCE MEDICAL, LLC

Primary DI Number: 00856331006163
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078797666 *Terms of Use

Device Description: CryoDose TA Topical Anesthetic Mini Medium Stream Spray, 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":	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: do not store near direct heat source
Storage Environment Temperature: less than 120 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 88 Milliliter

Device Record Status

Public Device Record Key: dc558606-522e-4967-8a7f-27a4970e94c5
Public Version Date: July 15, 2021
Public Version Number: 3
DI Record Publish Date: March 06, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10856331006160	10	00856331006163		In Commercial Distribution	Shipper

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(760)585-4849 ext: 0
Email: george@cryodose.com

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