FDA.report

Microscope Cover Glass

Primary DI
00810050851206
Brand
Microscope Cover Glass
Company
TYPENEX MEDICAL LLC
Model
MC0103
Device description
Microscope Cover Glass, 20mm x 20mm, # 1 Thickness
Published
2022-11-15
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

Product Codes

CodeName
KESCoverslips, Microscope Slide

Product Code Classifications

CodeDeviceSpecialtyClass
KESCoverslips, Microscope SlidePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810049689933PackageGS120In Commercial Distribution
00810050851206PackageGS110In Commercial Distribution
00812269038850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810049689933008100496899338100496899330810049689933
00810050851206008100508512068100508512060810050851206
00812269038850008122690388508122690388500812269038850

GMDN Terms

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

Regulatory Flags

DUNS number
600850213
Device count
1
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

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00810050855457Rad ControlRT03022025-05-23
00810050855471Rad ControlRT03012025-05-23
20810050855697Microscope SldiesLC01012025-02-03
20810050855703Microscope SlidesLC02032025-02-03
20810050855710Microscope SlidesLC01042025-02-03
20810050855727Microscope Slides LC01032025-02-03
20810050855734Microscope SlidesPS0202WXL2025-02-03
20810050855680Microscope SlidesPS0404W2025-01-21
00810050855631ThermoFlo®62412024-12-06
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20810050855673Microscope SlidesPS0201WXL2024-11-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00612479135468McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479135512McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479185388McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479185395McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
06979203760285Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdKES2026-01-07
30194484321551N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-09
30194484321285N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-08
30194484321292N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-08
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00849832023364Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832025641Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
10810041333985Epredia NEW ERIE SCIENTIFIC LLCKES2025-06-26
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00810041333032Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17
00810041333049Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17
00810041333056Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17
00810041333063Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17