FDA.reportPublic FDA data

Epredia

Primary DI
00673693228787
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Tissue Specimen Bags Medium, Qty.1000 Blue Nylon
Catalog number
6774009
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
2024-08-07
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

Product Codes#

Code, Name table
CodeName
IDZCassettes, Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDZCassettes, TissuePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693228787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693228787006736932287876736932287870673693228787

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system rinsing unitAn electrically-powered, non-patient-contact unit designed to be permanently integrated within a dental suction system (dry or wet type) to channel water into the suction piping, to dilute and allow for more effective removal of aspirated fluids (e.g., blood, saliva) from the system. It consists of fresh water and waste water connections, internal valves, sensors and an electronic switching mechanism.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00673693181723EprediaPen-Fix™61052024-11-19
00673693063494EprediaMicrotome Knife, 12 CM, C22220042024-10-29
00673693063500EprediaMicrotome Knife, 16 CM, C1520202024-10-29
00673693063753EprediaMicrotome Knife, 30CM, C1520502024-10-29
00673693063760EprediaMicrotome Knife, 12 CM, D1520602024-10-29
00673693063777EprediaMicrotome Knife, 16 CM, D1520702024-10-29
00673693063784EprediaMicrotome Knife, 22 CM, D1520802024-10-29
00673693063791EprediaMicrotome Knife, 25 CM, D1520902024-10-29
00673693063807EprediaMicrotome Knife, 30 CM, D1521002024-10-29
00673693063814EprediaTungsten Carbide Knife, 16 CM1521202024-10-29
00673693064200EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600102024-10-29
00673693064231EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600402024-10-29
00673693226707EprediaTungsten Carbide D-Profile Microtome Knives56010062024-10-29
00673693263177EprediaMicrotome Knife D-Profile 240 mm22220062024-10-29
00673693568074EprediaHistoPlast IM8331K2024-10-29
00673693220514EprediaMicrotome Knife C-Profile 240 mm22220052024-10-28
00673693232913EprediaStainless-Steel Microtome Knives 12.5 cm76192024-10-28
00673693233149EprediaStandard Microtome Knife 125 mm77022024-10-28
00673693233187EprediaStandard Microtome Knife 250 mm77042024-10-28
00673693233200EprediaStainless-Steel Microtome Knives 18.5 cm77192024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051663626927EprediaSHANDON DIAGNOSTICS LIMITEDIDZ2026-03-11
20194484321660N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321677N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321684N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321691N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321707N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321714N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321752N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321219N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321226N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321356N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321363N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321370N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321387N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321394N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321400N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
00849832001003Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001010Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001027Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001034Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001041Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001058Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832003090Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832025818Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832025825Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832025832Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832000808Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20
00849832002567Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20
00849832002918Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20
00849832002925Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20