AccessGUDID - DEVICE: MARK3 (D7961330PI0)

GUDID

Device Identifier (DI) Information

Brand Name: MARK3
Version or Model: 1330PI
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CARGUS INTERNATIONAL, INC

Primary DI Number: D7961330PI0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 096191093 *Terms of Use

Device Description: Tray Covers Pink Ritter B 8-1/2" x 12-1/4" 1,000/cs. - MARK3

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?
63780	Laboratory instrument/analyser absorbent liner IVD	A non-sterile sheet or pad made from natural materials (e.g., cotton, paper) intended to be used to absorb spilt liquids onboard a liquid-handling laboratory analyser or instrument. It is intended to create a barrier to contamination, help reduce cleaning requirements, and protect the analyser/instrument from damage (e.g., corrosion). The device is typically placed inside a tray, bin, or other specific area of the analyser/instrument where liquids are likely to spill or splash during in vitro diagnostic procedures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRD	Unit, Operative Dental, Accessories

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
Special Storage Condition, Specify: Store in cool, dry place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 916e842d-7aa2-4906-ae11-8a70a82778c0
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: April 27, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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