FDA.report

Globe Scientific

Primary DI
00840095604239
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
1415-15
Device description
Microscope Cover Glass, 24mm x 50mm, # 1.5 Thickness, 1 oz./Vacuum Pack, 10 Packs/Box (10 oz.)
Published
2019-11-26
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
00840095604246PackageGS120In Commercial Distribution
00840095604239PrimaryGS10
00840095610582Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095604246008400956042468400956042460840095604246
00840095604239008400956042398400956042390840095604239
00840095610582008400956105828400956105820840095610582

GMDN Terms

TermDefinition
Microscope slide coverslipA 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
106793995
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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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00840095689656Globe Scientific 154105FS2025-07-07

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06979203760285Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdKES2026-01-07
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00810041333032Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17
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