FDA.report

Disposable Base Mold

Primary DI
30810050854277
Brand
Disposable Base Mold
Company
TYPENEX MEDICAL LLC
Model
CM0216
Device description
Disposable Base Mold, 30x20x12
Published
2022-02-24
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
IDZCassettes, Tissue

Product Code Classifications

CodeDeviceSpecialtyClass
IDZCassettes, TissuePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30810050854277PackageGS150In Commercial Distribution
40810050854274PackageGS110In Commercial Distribution
00810050854276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3081005085427730810050854277
4081005085427440810050854274
00810050854276008100508542768100508542760810050854276

GMDN Terms

TermDefinition
Histology tissue cassette IVD, laboratory processingA 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
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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