FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
10630094172504
Brand
Bioseal Inc.
Company
BIOSEAL
Model
17250/48
Device description
Petri Dish Culture
Published
2023-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KIZDISH, TISSUE CULTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIZDish, Tissue CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094172504PackageGS148In Commercial Distribution
00630094172507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009417250410630094172504
00630094172507006300941725076300941725070630094172507

GMDN Terms#

Term, Definition table
TermDefinition
Tissue culture/microbiology petri dish, single-useA device formed as a round and shallow-sided dish intended to be used to grow and contain tissue and/or microbial cultures for laboratory procedures; it is not intended for in vitro fertilization (IVF). It is designed to fit into a range of laboratory instruments and analysers where various processes can be carried out. The device is typically made of glass or plastic and includes a cover; it may be colour coded. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186968939
Device count
1
DM exempt
true
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
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
00630094198514Bioseal Inc.19851NS/1002023-12-07
00630094171470Bioseal Inc.17147/012023-09-18
00630094017501Bioseal Inc.1750/502023-09-25
10630094481026Bioseal Inc.DURA102/1002025-05-29
10630094481231Bioseal Inc.DURA123/1002025-05-29
10630094483006Bioseal Inc.DURA300/1002025-05-29
10630094485055Bioseal Inc.DURA505/1002025-05-29
10630094485123Bioseal Inc.DURA512/1002025-05-29
10630094487028Bioseal Inc.DURA702/1002025-05-29
10630094487059Bioseal Inc.DURA705/1002025-05-29
10630094487301Bioseal Inc.DURA730/1002025-05-29
10630094489022Bioseal Inc.DURA902/1002025-05-29
00630094481029Bioseal Inc.DURA102/1002025-05-29
00630094481234Bioseal Inc.DURA123/1002025-05-29
00630094483009Bioseal Inc.DURA300/1002025-05-29
00630094485058Bioseal Inc.DURA505/1002025-05-29
00630094485126Bioseal Inc.DURA512/1002025-05-29
00630094487021Bioseal Inc.DURA702/1002025-05-29
00630094487052Bioseal Inc.DURA705/1002025-05-29
00630094487304Bioseal Inc.DURA730/1002025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194484321731N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-11
00194484321734N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-11
10194484321236N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-08
10194484321243N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-08
00194484321239N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-08
00194484321246N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KIZ2025-08-08
00840117331099LabChoice Petri Dishes, Stackable, 90 x 15 mm, Sterile Dynarex CorporationKIZ2025-06-16
00840117331105LabChoice Petri Dishes, Stackable, Sterile, 150 x 15 mm Dynarex CorporationKIZ2025-06-16
00810180842198LabChoice Petri Dishes, Stackable, 90 x 15 mm, Sterile Dynarex CorporationKIZ2025-06-16
00810180842204LabChoice Petri Dishes, Stackable, Sterile, 150 x 15 mm Dynarex CorporationKIZ2025-06-16
00850043803041Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00850043803058Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00850043803065Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00850043803072Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00850043803089Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00850043803096Planet-Safe®Diversified Biotech, Inc.KIZ2024-10-07
00630094176512Bioseal Inc.BIOSEALKIZ2023-10-02
00630094765112Bioseal Inc.BIOSEALKIZ2023-10-02
10630094176519Bioseal Inc.BIOSEALKIZ2023-10-02
10630094765119Bioseal Inc.BIOSEALKIZ2023-10-02
00630094172408Bioseal Inc.BIOSEALKIZ2023-09-18
00630094172439Bioseal Inc.BIOSEALKIZ2023-09-18
00630094172507Bioseal Inc.BIOSEALKIZ2023-09-18
10630094172405Bioseal Inc.BIOSEALKIZ2023-09-18
10630094172436Bioseal Inc.BIOSEALKIZ2023-09-18
00850043803010Planet-Safe®Diversified Biotech, Inc.KIZ2023-07-15
00850043803027Planet-Safe®Diversified Biotech, Inc.KIZ2023-07-15
06974669350292MDHCMDHC Life Technologies (Kunshan) Co., LTD.KIZ2023-07-06
14039943000849CELLMASTERGreiner Bio - One GmbHKIZ2023-04-01
14039943000856CELLMASTERGreiner Bio - One GmbHKIZ2023-04-01