FDA.reportPublic FDA data

Globe Scientific

Primary DI
00840095604475
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
190195
Device description
Biopsy Pad for Cassettes, Foam, Blue, 30.2mm x 25.4mm x 2mm, 1000/Pack
Published
2019-12-18
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

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
00840095604482PackageGS110In Commercial Distribution
00840095604499PackageGS125In Commercial Distribution
00840095604505PackageGS150In Commercial Distribution
00840095604475PrimaryGS10
00840095610766Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095604482008400956044828400956044820840095604482
00840095604499008400956044998400956044990840095604499
00840095604505008400956045058400956045050840095604505
00840095604475008400956044758400956044750840095604475
00840095610766008400956107668400956107660840095610766

GMDN Terms#

Term, Definition table
TermDefinition
Histological tissue cassette biopsy insert IVDA flexible and porous material designed to securely hold a biopsy specimen within a tissue cassette, to prevent loss of the specimen during specimen processing (e.g., fixation, dehydration, infiltration) in preparation for subsequent cytological or histological examination. The flexible and porous material (e.g., paper, synthetic polymer) is intended to allow infiltration of reagents and maximize fluid-exchange during tissue processing. It is available in various forms (e.g., sheet, bag, foam pad) and is placed in a tissue processing cassette, with the biopsy specimen wrapped or contained inside it. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106793995
Device count
1000
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840095681674Globe ScientificGCC-P2026-03-16
00840095689441Globe Scientific 154005R2025-07-07
00840095689458Globe Scientific 154020R2025-07-07
00840095689465Globe Scientific 154035R2025-07-07
00840095689472Globe Scientific 154005RS2025-07-07
00840095689489Globe Scientific 154020RS2025-07-07
00840095689496Globe Scientific 154035RS2025-07-07
00840095689502Globe Scientific 154105RS2025-07-07
00840095689519Globe Scientific 154120RS2025-07-07
00840095689526Globe Scientific 154135RS2025-07-07
00840095689533Globe Scientific 154205RS2025-07-07
00840095689540Globe Scientific 154220RS2025-07-07
00840095689557Globe Scientific 154235RS2025-07-07
00840095689595Globe Scientific 154005F2025-07-07
00840095689601Globe Scientific 154020F2025-07-07
00840095689618Globe Scientific 154035F2025-07-07
00840095689625Globe Scientific 154005FS2025-07-07
00840095689632Globe Scientific 154020FS2025-07-07
00840095689649Globe Scientific 154035FS2025-07-07
00840095689656Globe Scientific 154105FS2025-07-07

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