AccessGUDID - DEVICE: Globe Scientific (00840095655699)

GUDID

Device Identifier (DI) Information

Brand Name: Globe Scientific
Version or Model: GCH-24-ROT-1.5-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GLOBE SCIENTIFIC INC.

Primary DI Number: 00840095655699
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106793995 *Terms of Use

Device Description: Rotor for use with GCH-24 Series Hematocrit Centrifuges, with Lid, Fixing Clips and O-Ring, 14000rpm max, 24-Place for 1.5mL and 2.0mL Microcentrifuge Tubes

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):	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?
37532	Centrifuge rotor, fixed angle	A device, commonly called the rotor, or rotor head, used as a component in a centrifuge. It is designed with the tube holding bores formed at a pre-set angle and pattern. It is horizontally attached at the top of the vertical shaft which is part of the electrically-powered drive unit and the samples to be centrifuged are placed in this rotor.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKG	Centrifuge, Hematocrit

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: c1e36d35-4e14-4640-8d8e-d47082f93a67
Public Version Date: July 13, 2023
Public Version Number: 1
DI Record Publish Date: July 05, 2023