AccessGUDID - DEVICE: Globe Scientific (00840095636735)

GUDID

Device Identifier (DI) Information

Brand Name: Globe Scientific
Version or Model: 6286
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GLOBE SCIENTIFIC INC.

Primary DI Number: 00840095636735
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 106793995 *Terms of Use

Device Description: Centrifuge Tube, 15mL, Attached Blue Flat Top Screw Cap, PP, Printed Graduations, STERILE, 50/Rack, 10 Racks/Unit

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?
43761	Centrifuge tube IVD	A tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMH	Container, Specimen, Sterile

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: Yes
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: 7133565f-f424-4802-8ee3-ceef1ef8ba01
Public Version Date: July 11, 2023
Public Version Number: 1
DI Record Publish Date: July 03, 2023