AccessGUDID - DEVICE: Tissue-Tek Genie® (00615233001979)

GUDID

Device Identifier (DI) Information

Brand Name: Tissue-Tek Genie®
Version or Model: 8383-C010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8383-C010
Company Name: SAKURA FINETEK U.S.A., INC.

Primary DI Number: 00615233001979
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 179135769 *Terms of Use

Device Description: anti-IgG Rabbit Monoclonal Antibody [RM116], 10 RTU capsules

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:	Yes
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?
63911	Human immunoglobulin G (IgG) rabbit conjugate antibody reagent IVD	One or multiple leporine immunoglobulins (sourced from a rabbit) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin G (IgG) antibodies. The immunoglobulin molecules are conjugated or bound by additional substances (e.g., fluorescent markers, peroxidase enzymes) for the detection of immune complexes in clinical specimens.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NJT	IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

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: b7413f81-1fd6-4ed3-9b1a-1abc27427acc
Public Version Date: January 09, 2020
Public Version Number: 1
DI Record Publish Date: January 01, 2020