FDA.report

Histoplex

Primary DI
00840165500218
Company
Starplex Scientific Corp.
Model
H1202-FL
Device description
Specimen Container, 120 ml, Yellow Cap, Affixed 10% Buffered Formalin Label, Non-Sterile
Published
2025-05-30
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
859771235
Device count
75
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
00840165500218PackageGS14In Commercial Distribution
10840165500208PrimaryGS10
00840165500201Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00840165500218PackageGS1410840165500208In Commercial Distribution
10840165500208PrimaryGS10
00840165500201Unit 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 tissue specimen container IVD, no additiveA covered receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part 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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00840165500485LeakbusterB1252-1O2025-05-28
00840165500508LeakbusterB1202-1O-OR2025-05-28
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00840165500096StarCLICK 100B1002-YCC2025-05-28
00840165500119LeakbusterB902-1YN2025-05-28
00840165500133LeakbusterWB902-1YN2025-05-28
00840165500157LeakbusterB1202-1YN2025-05-28
00840165500171LeakbusterWB902-1ONTS2025-05-28
00840165500195HistoplexH902-FL2025-05-28
00840165500294Leakbuster 3TW902-O2025-05-28
00840165500355LeakbusterB902-1W2025-05-28
00840165500393LeakbusterB902-1OTS2025-05-28
00840165500416LeakbusterB902-1YNTS2025-05-28
00840165500430LeakbusterB902-1WNLTS2025-05-28
00840165500454LeakbusterWB902-1OTS2025-05-28
00840165500478LeakbusterWB902-1WTSS2025-05-28

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