AccessGUDID - DEVICE: Globe Scientific (00840095601269)

GUDID

Device Identifier (DI) Information

Brand Name: Globe Scientific
Version or Model: 112030
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GLOBE SCIENTIFIC INC.

Primary DI Number: 00840095601269
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106793995 *Terms of Use

Device Description: Tube, Urine Centrifuge, 12mL, with Sediment Bulb and Flared Top, PS, Graduated to 10 mL, 500/Bag, 3 Bags/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
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 35fd4681-2a48-417f-a842-9a0c41efd97c
Public Version Date: July 04, 2023
Public Version Number: 3
DI Record Publish Date: November 27, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00840095601245	500	00840095601269	In Commercial Distribution	Box
00840095601252	1500	00840095601269	In Commercial Distribution	Case
00840095643382	250	00840095601269	In Commercial Distribution	bag