FDA.reportPublic FDA data

Microscope Cover Glass

Primary DI
00812269038966
Brand
Microscope Cover Glass
Company
TYPENEX MEDICAL LLC
Model
MC0116
Device description
Microscope Cover Glass, 24mm x 40mm, # 1 Thickness
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KESCoverslips, Microscope Slide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KESCoverslips, Microscope SlidePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810049689940PackageGS110In Commercial Distribution
00810049689957PackageGS120In Commercial Distribution
00812269038966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810049689940008100496899408100496899400810049689940
00810049689957008100496899578100496899570810049689957
00812269038966008122690389668122690389660812269038966

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide coverslip IVDA thin piece of glass or a plastic sheath placed over a specimen on a microscope slide, to serve as a physical barrier to protect the specimen from mechanical forces and environmental exposure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600850213
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810050855850Microscope SlidesPS0404G2026-05-14
10810050855867Microscope SlidesPS0404L2026-05-14
10810050855874Microscope SlidesPS0404N2026-05-14
10810050855881Microscope SlidesPS0404P2026-05-14
10810050855898Microscope SlidesPS0404Y2026-05-14
10810050855904Embedding CassetteEC0616YXT-LASER2026-05-14
10810050855911Embedding CassetteEC0616PXT-LASER2026-05-14
10810050855928Embedding CassetteEC0616WXT-LASER2026-05-14
10810050855935Embedding CassetteEC0616EXT-LASER2026-05-14
10810050855843Rad ControlRT0301XBA2026-05-06
10810050855836Microscope SlidesLC0105B2026-03-23
20810050855833Microscope SlidesLC0105B2026-03-23
B050SL1000020Sterile LabelsSL-1000022026-03-17
B050SL1000021Sterile LabelsSL-1000022026-03-17
00810050851923Specimen Collection SwabSW0202SW02022020-06-01
00810050851909Specimen Collection SwabSW0102SW01022020-06-01
00810050852388Anterior Nasal SwabSW0302SW03022020-08-20
00810050855815ThermoFlo®60612026-01-26
00810050855808Typenex Introducer SetMS2335S2025-11-17
10810050855805Typenex Introducer SetMS2335S2025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612479135475McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479135505McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479160415McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479160422McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
10194484321557N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-09
10194484321281N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-08
10194484321298N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-08
20849832016001Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832016018Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832016025Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832016032Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832016049Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017640Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017701Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017756Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017763Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017794Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832022705Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832022736Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832023207Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832023351Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832023368Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832025645Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00810041333988Epredia NEW ERIE SCIENTIFIC LLCKES2025-06-26
10849832013454Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-06-04
00810041333308Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17
04064279008088Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26
04064279008262Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26
04064279008637Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26
04064279008682Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26