FDA.report

Epredia

Primary DI
00673693474368
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Tissue Specimen Bags Small, Qty 1000 White Nylon H
Catalog number
6774022
Device description
Tissue Specimen Bags are designed to contain small tissue fragments and biopsies during tissue processing. Acid-resistant bags feature all of the benefits of nylon specimen bags, plus offer acid resistance for decalcification. Tissue Specimen bags are used in addition to tissue cassettes during processing. They are available in blue nylon (mono-filament, hydrophilic coated); white nylon (mono-filament, mono-filament - hydrophilic coated and polyester acid-resistant, woven).
Published
2024-09-10
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
00673693474368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693474368006736934743686736934743680673693474368

GMDN Terms

TermDefinition
General tissue specimen container IVD, no additiveA covered receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
929504710
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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