FDA.report

Starplex

Primary DI
10840165400867
Company
Pretium Canada Packaging ULC
Model
V102-CA
Device description
10 ml Urine Preservative Vial, for Urine Culture and Urinalysis, Sterile
Published
2025-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
246665038
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00840165400860PrimaryGS10
10840165400867Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00840165400860PrimaryGS10
10840165400867Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FMHContainer, Specimen, Sterile1Pathology864.3250NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Non-evacuated urine specimen container IVD, preservativeA covered receptacle containing one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] intended to be used for the collection, preservation, and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. It may include a disposable pipette to transfer the urine specimen into a secondary container (not included). This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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