AccessGUDID - DEVICE: Globe Scientific (00840095657747)

GUDID

Device Identifier (DI) Information

Brand Name: Globe Scientific
Version or Model: 6102S-R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GLOBE SCIENTIFIC INC.

Primary DI Number: 00840095657747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 106793995 *Terms of Use

Device Description: 16x101mm tube, separate red screwcap, sterile, self-standing,200 tube/bag,1000cap/bag,case liner.

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?
46238	General laboratory container, single-use, sterile	A sterile container (e.g., test tube, bottle, cup) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KDT	Container, Specimen Mailer And Storage, 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: 19388ce7-47b8-4218-bf0e-97953521bab6
Public Version Date: October 16, 2020
Public Version Number: 1
DI Record Publish Date: October 08, 2020