AccessGUDID - DEVICE: Vitagel (30808232000833)

GUDID

Device Identifier (DI) Information

Brand Name: Vitagel
Version or Model: 2090-0036
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2090-0036
Company Name: Stryker Corporation

Primary DI Number: 30808232000833
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2018
Device Count: 5
Labeler D-U-N-S® Number*: 149183167 *Terms of Use

Device Description: Spray Set

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:	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?
47185	Haematological concentrate system delivery unit	A mains electricity (AC-powered) device that is a component of a haematological concentrate system and used to deliver a processed haematological concentrate through tubing to a hand-held applicator (typically a spraypen or endoscopic applicator). Upon activation (e.g., via a foot-switch operated by surgical staff) it typically generates a low pressure for the delivery of the concentrate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052173	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Dry and Ambient

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b9afbfb-37ff-43bc-ac3a-2fcbebcd8557
Public Version Date: May 16, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2016