FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
10630094173167
Brand
Bioseal Inc.
Company
BIOSEAL
Model
17316/20
Device description
Test Tube w/Screw Cap
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
KJGTUBE, TISSUE CULTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJGTube, Tissue CulturePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094173167PackageGS120In Commercial Distribution
00630094173160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009417316710630094173167
00630094173160006300941731606300941731600630094173160

GMDN Terms#

Term, Definition table
TermDefinition
Culture tubeA sterile glass or plastic tube-like container used to hold a culture specimen. 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
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
00630094489025Bioseal Inc.DURA902/1002025-05-29
00630094480503Bioseal Inc.DURA050/1002025-05-28
10630094292240Bioseal Inc.32-922-4/202024-01-10
10630094335404Bioseal Inc.33-540/202024-01-10
10630094055111Bioseal Inc.551S/202024-01-29
10630094055135Bioseal Inc.551L/202024-01-29
10630094055142Bioseal Inc.551M/202024-01-29
10630094055197Bioseal Inc.551R/202024-01-29
10630094061501Bioseal Inc.6150/252024-01-29
10630094061518Bioseal Inc.6151/252024-01-29
10630094061525Bioseal Inc.6152/502024-01-29
10630094064243Bioseal Inc.6424/1202024-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816203023800AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023845AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023852AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023869AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023876AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023883AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023944AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023968AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023975AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023982AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203023999AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203024149AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203024180AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
10816203024197AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
20816203024330AccessoriesORIGEN BIOMEDICAL, INC.KJG2025-06-18
00810180841726LabChoice Plastic Test Tubes, Polystyrene, 12 x 75 mm Dynarex CorporationKJG2025-04-17
00810180841733LabChoice Plastic Test Tubes, Polypropylene, 12 x 75 mm Dynarex CorporationKJG2025-04-17
00810180841740LabChoice Plastic Test Tubes, Polystyrene, 13 x 75 mm Dynarex CorporationKJG2025-04-17
00810180841757LabChoice Plastic Test Tubes, Polypropylene, 13 x 75 mm Dynarex CorporationKJG2025-04-17
00810180841764LabChoice Plastic Test Tubes, Polystyrene, 13 x 100 mm Dynarex CorporationKJG2025-04-17
00810180841771LabChoice Plastic Test Tubes, Polystyrene, 16 x 100 mmDynarex CorporationKJG2025-04-17
00810180841788LabChoice Plastic Test Tubes, Polypropylene, 16 x 100 mm Dynarex CorporationKJG2025-04-17
00810180841795LabChoice Plastic Test Tubes, Polypropylene, 13 x 100 mm Dynarex CorporationKJG2025-04-17
00810180841221LabChoice Glass Test Tubes, 10 x 75 mm Dynarex CorporationKJG2025-03-05
00810180841238LabChoice Glass Test Tubes, 12 x 75 mm Dynarex CorporationKJG2025-03-05
00810180841245LabChoice Glass Test Tubes, 13 x 100 mm Dynarex CorporationKJG2025-03-05
00810180841252LabChoice Glass Test Tubes, 16 x 100 mm Dynarex CorporationKJG2025-03-05
00810180841153LabChoice Tubes, With Dual Position Cap, Polystyrene Peel Pack, 17 x 100 mm Dynarex CorporationKJG2025-03-03
00810180841122LabChoice Culture Tubes,With Dual Position Cap, Polystyrene Peel Pack,12 x 75mmDynarex CorporationKJG2025-03-03
00810180841160LabChoice Culture Tubes,With Dual Position Cap, Polystyrene Peel Pack Dynarex CorporationKJG2025-03-03