AccessGUDID - DEVICE: Histoplex (10840165401062)

GUDID

Device Identifier (DI) Information

Brand Name: Histoplex
Version or Model: H602-FL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pretium Canada Packaging ULC

Primary DI Number: 10840165401062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 246665038 *Terms of Use

Device Description: Specimen Container, 60 ml, Yellow Cap, 10% Buffered Formalin Label, Non-Sterile.

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?
63838	General tissue specimen container IVD, no additive	A covered receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNK	Container, Specimen Mailer And Storage, 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: 5e02c3e0-fa2b-4742-99a0-d62479ec52ec
Public Version Date: March 12, 2025
Public Version Number: 1
DI Record Publish Date: March 04, 2025