FDA.report

Leakbuster

Primary DI
00840165500478
Brand
Leakbuster
Company
Starplex Scientific Corp.
Model
WB902-1WTSS
Device description
Specimen Container, 90 ml Wide Mouth, White Cap, Applied Temperature Strip, Sterile.
Published
2025-05-28
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

Product Codes

CodeName
FMHContainer, Specimen, Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840165500478PackageGS14In Commercial Distribution
10840165500468PrimaryGS10
00840165500461Unit of UseGS10

GMDN Terms

TermDefinition
Drug-testing urine specimen container IVDA covered plastic receptacle with a temperature strip and/or tamperproof seal intended to be used for the collection, and preservation and/or transport, of a urine specimen for drug testing and/or other investigation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
859771235
Device count
100
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840165500218HistoplexH1202-FL2025-05-30
00840165500300Leakbuster 3TW952-O2025-05-28
00840165500324Leakbuster 3TW902-O-OR2025-05-28
00840165500362LeakbusterB1202-1W-OR2025-05-28
00840165500485LeakbusterB1252-1O2025-05-28
00840165500508LeakbusterB1202-1O-OR2025-05-28
00840165500058LeakbusterWB902-1O2025-05-28
00840165500072StarCLICK 100B1002-OCC2025-05-28
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

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H1083540173Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540203Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H108117393CorningCorning IncorporatedFMH2026-01-14
30815112021475Transpec Specimen Radiography DeviceBracco Diagnostics Inc.FMH2026-01-09
30815112021482TranspecBracco Diagnostics Inc.FMH2026-01-09
00810124536923Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyFMH2025-12-05
40198459304638MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
40198459382964MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
20816203023913O-Wrap™ BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024019TissueVault™ Cell & Tissue Freezing BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024095O-Wrap™ BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024156TissueVault™ Cell & Tissue Freezing BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
40080196035299MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40884389226262MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40888277117922MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40198459351328MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-06-02
00840165500300Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500324Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500362LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500485LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500508LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500058LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500072StarCLICK 100Starplex Scientific Corp.FMH2025-05-28
00840165500294Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500355LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500393LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500454LeakbusterStarplex Scientific Corp.FMH2025-05-28