AccessGUDID - DEVICE: Globe Scientific (00840095608299)

GUDID

Device Identifier (DI) Information

Brand Name: Globe Scientific
Version or Model: 6527FL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GLOBE SCIENTIFIC INC.

Primary DI Number: 00840095608299
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 96
Labeler D-U-N-S® Number*: 106793995 *Terms of Use

Device Description: Pre-Filled Container with Click Close Lid: Tite-Rite, 120mL (4oz), PP, Filled with 60mL of 10% Neutral Buffered Formalin, Attached Hazard Label, 24/Box, 4 Boxes/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?
57926	General tissue specimen container IVD, formal saline	A covered plastic receptacle containing 10% formal saline preservative solution (formalin) intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) for analysis and/or other investigation. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NNI	Container, Specimen, Non-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: 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: bed11eb1-d145-4971-8a0a-3a39116a62eb
Public Version Date: December 04, 2019
Public Version Number: 1
DI Record Publish Date: November 26, 2019