FDA.report

MARK3

Primary DI
D7966118CS2
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
6118CS
Catalog number
6118CS
Device description
Self Seal 5-1/4" x 11" (5-1/4" x 10") Sterilization Pouches 15/cs. - MARK3
Published
2022-05-23
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
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications

CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7966118CS1PrimaryHIBCC0
D7966118CS2Unit of UseHIBCC0

GMDN Terms

TermDefinition
Sterilization container linerA non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store In Cool Dry Place

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
096191093
Device count
15
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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