FDA.report

Embedding Cassette

Primary DI
00810049680992
Brand
Embedding Cassette
Company
TYPENEX MEDICAL LLC
Model
EC0204AXT
Device description
Biopsy, One Compartment, 0.9 x 0.9 mm, 45°, Lid Attached, Front Hinge, Aqua, Taped
Published
2022-11-16
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
00810049680992PrimaryGS10
00812269035231Unit of UseGS10

GMDN Terms

TermDefinition
Tissue embedding mould IVD, single-useA plastic container of square or rectangular shape intended to be used to embed tissue specimens into an embedding medium (e.g., paraffin wax) to form a solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It is typically made of synthetic polymer materials (e.g., plastic) This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
600850213
Device count
2000
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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