FDA.report

Globe Scientific

Primary DI
00840095600446
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
1094A
Device description
Cassette, Tissue Embedding with Attached Lid, 35° Writing Area, AQUA, 500/Dispenser Box, 2 Boxes/Unit
Published
2019-11-27
Public version status
Update
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
IDZCassettes, Tissue

Product Code Classifications

CodeDeviceSpecialtyClass
IDZCassettes, TissuePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840095600453PackageGS12In Commercial Distribution
00840095600460PackageGS13In Commercial Distribution
00840095600446PrimaryGS10
00840095608756Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095600453008400956004538400956004530840095600453
00840095600460008400956004608400956004600840095600460
00840095600446008400956004468400956004460840095600446
00840095608756008400956087568400956087560840095608756

GMDN Terms

TermDefinition
Histological tissue cassette IVDA small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a synthetic polymer container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
106793995
Device count
500
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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00840095689632Globe Scientific 154020FS2025-07-07
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00840095689656Globe Scientific 154105FS2025-07-07

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