AccessGUDID - DEVICE: Vitagel (00808232001389)

GUDID

Device Identifier (DI) Information

Brand Name: Vitagel
Version or Model: 2113-0211
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2113-0211
Company Name: Stryker Corporation

Primary DI Number: 00808232001389
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 149183167 *Terms of Use

Device Description: RT3 REACH9 Malleable Applicator

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:	Yes
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?
47186	Haematological concentrate/haemostatic agent applicator	A hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMF	Agent, absorbable hemostatic, collagen based

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P050044	028

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
Storage Environment Temperature: between 20 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e9d5b54-50ea-4b42-b24e-e5fcb38ad60c
Public Version Date: November 06, 2020
Public Version Number: 5
DI Record Publish Date: September 24, 2014