AccessGUDID - DEVICE: Epredia (00673693228862)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Tissue Specimen Bags Medium, Qty 250 White Acid-Resistant
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6774050
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693228862
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Tissue Specimen Bags are designed to contain small tissue fragments and biopsies during tissue processing. Acid-resistant bags feature all of the benefits of nylon specimen bags, plus offer acid resistance for decalcification. Tissue Specimen bags are used in addition to tissue cassettes during processing. They are available in blue nylon (mono-filament, hydrophilic coated); white nylon (mono-filament, mono-filament - hydrophilic coated and polyester acid-resistant, woven).

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
IDZ	Cassettes, Tissue

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: 9c7a510c-f00b-4f1d-8c7e-78ec2560f92a
Public Version Date: September 18, 2024
Public Version Number: 1
DI Record Publish Date: September 10, 2024