AccessGUDID - DEVICE: HemosIL Q.F.A. Thrombin (Bovine)

GUDID

Device Identifier (DI) Information

Brand Name: HemosIL Q.F.A. Thrombin (Bovine) - 2 mL
Version or Model: 00020301800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00020301800
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950573500
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: HemosIL Q.F.A. Thrombin (Bovine) - 2 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":	No
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?
55997	Fibrinogen assay (factor I) IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen, using a clotting method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GIS	TEST, FIBRINOGEN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963902	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
Special Storage Condition, Specify: Unopened reagent is stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 21c8ac08-6592-43e1-a67e-d51532986355
Public Version Date: July 13, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2016