AccessGUDID - DEVICE: Bio-Rad Laboratories, Inc. (00847865019354)

GUDID

Device Identifier (DI) Information

Brand Name: Bio-Rad Laboratories, Inc.
Version or Model: 12000668
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12000668
Company Name: Bio-RAD Laboratories, Inc.

Primary DI Number: 00847865019354
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844766394 *Terms of Use

Device Description: Slide Blotters, 24-well

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?
58232	Cotton wool roll	A device designed as an absorbent mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector or the home; it is not in the form of a bandage or dedicated dressing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DBM	ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K810863	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20 Each
Device Size Text, specify: 24 wells

Device Record Status

Public Device Record Key: 6264f908-2e43-430c-be00-fa18c29c5c5d
Public Version Date: February 20, 2023
Public Version Number: 5
DI Record Publish Date: September 12, 2016