FDA.report

Starplex

Primary DI
00840165400976
Company
Pretium Canada Packaging ULC
Model
V302-F
Device description
Specimen Container, 30 ml, Fecal Spork, Non-Sterile.
Published
2025-03-04
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

Regulatory Flags

DUNS number
246665038
Device count
200
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
00840165400976PackageGS15In Commercial Distribution
10840165400966PrimaryGS10
00840165400969Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00840165400976PackageGS1510840165400966In Commercial Distribution
10840165400966PrimaryGS10
00840165400969Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
NNIContainer, Specimen, Non-Sterile1Pathology864.3250NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

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00840165400372Starswab Dry SwabS092025-02-21
00840165400396Starswab Dry SwabS09D2025-02-21
00840165400419Starswab Anaerobic Transport SystemS120-02025-02-21
00840165400433Starswab Anaerobic Transport SystemS120-D2025-02-21
00840165400457Starswab Anaerobic Transport SystemS120-52025-02-21
00840165400471Starswab Multitrans SystemS160-02025-02-21
00840165400495Starswab Multitrans SystemS160-1002025-02-21
00840165400518Starswab Multitrans SystemS160-FL2025-02-21
00840165400532Starswab Multitrans SystemS160-FL-COM2025-02-21
00840165400556Starswab Multitrans SystemS160-NASO2025-02-21
00840165400570Starswab Multitrans SystemS160-NASO-12025-02-21

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