FDA.report

MARK3

Primary DI
D7961330GR0
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
1330GR
Device description
Tray Covers Green Ritter B 8-1/2" x 12-1/4" 1,000/cs. - MARK3
Published
2021-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7961330GR0PrimaryHIBCC0

GMDN Terms

TermDefinition
Laboratory analyser/instrument absorbent liner IVDA 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place.

Sterilization Methods

Method

Regulatory Flags

DUNS number
096191093
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D79619122MARK3191219122023-11-09

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