FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
10630094170357
Brand
Bioseal Inc.
Company
BIOSEAL
Model
17035/50
Device description
Microscope Slide
Published
2023-09-18
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

Product Codes#

Code, Name table
CodeName
KEWSLIDES, MICROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094170357PackageGS150In Commercial Distribution
00630094170350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009417035710630094170357
00630094170350006300941703506300941703500630094170350

GMDN Terms#

Term, Definition table
TermDefinition
General specimen microscopy slide IVD, single-useA glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186968939
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630094481029Bioseal Inc.DURA102/1002025-05-29
00630094481234Bioseal Inc.DURA123/1002025-05-29
00630094483009Bioseal Inc.DURA300/1002025-05-29
00630094485058Bioseal Inc.DURA505/1002025-05-29
00630094485126Bioseal Inc.DURA512/1002025-05-29
00630094487021Bioseal Inc.DURA702/1002025-05-29
00630094487052Bioseal Inc.DURA705/1002025-05-29
00630094487304Bioseal Inc.DURA730/1002025-05-29
00630094489025Bioseal Inc.DURA902/1002025-05-29
00630094480503Bioseal Inc.DURA050/1002025-05-28
10630094292240Bioseal Inc.32-922-4/202024-01-10
10630094335404Bioseal Inc.33-540/202024-01-10
10630094055111Bioseal Inc.551S/202024-01-29
10630094055135Bioseal Inc.551L/202024-01-29
10630094055142Bioseal Inc.551M/202024-01-29
10630094055197Bioseal Inc.551R/202024-01-29
10630094061501Bioseal Inc.6150/252024-01-29
10630094061518Bioseal Inc.6151/252024-01-29
10630094061525Bioseal Inc.6152/502024-01-29
10630094064243Bioseal Inc.6424/1202024-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20810050855833Microscope SlidesTYPENEX MEDICAL LLCKEW2026-03-23
00612479124448McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124455McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124462McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160651McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160668McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160675McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
09551020410092PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410320PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410337PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410344PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410351PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410368PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
20194484321585N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
20194484321592N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
20194484321530N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321561N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321578N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321264N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321271N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321301N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321318N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321325N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321332N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321349N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
00849832023210Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024170Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024316Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024323Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024354Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23