AccessGUDID - DEVICE: Epredia (00673693228800)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Tissue Specimen Bags Large, Qty. 500 Blue Nylon
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6774011
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693228800
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?
63830	Dental suction system rinsing unit	An electrically-powered, non-patient-contact unit designed to be permanently integrated within a dental suction system (dry or wet type) to channel water into the suction piping, to dilute and allow for more effective removal of aspirated fluids (e.g., blood, saliva) from the system. It consists of fresh water and waste water connections, internal valves, sensors and an electronic switching mechanism.	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: 4ab6d037-e49e-4f62-a8d6-c8aff59f38b5
Public Version Date: August 15, 2024
Public Version Number: 1
DI Record Publish Date: August 07, 2024