FDA.reportPublic FDA data

LabChoice Culture Tubes,With Dual Position Cap, Polystyrene Peel Pack,12 x 75mm

Primary DI
00810180841122
Brand
LabChoice Culture Tubes,With Dual Position Cap, Polystyrene Peel Pack,12 x 75mm
Company
Dynarex Corporation
Model
42305
Device description
With Graduated Markings
Published
2025-03-03
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
KJGTube, Tissue Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJGTube, Tissue CulturePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117335035PrimaryGS10
00810180841122Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117335035008401173350358401173350350840117335035
00810180841122008101808411228101808411220810180841122

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
008124539
Device count
500
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
true
Sterilization required before use
false

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00840117307681Ever-Soft Pommel Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106802021-04-22
00840117307704Ever-Soft Pommel Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106812021-04-22
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00616784070414Hydraulic Patient Lift107042019-09-30
00616784070018Electric Patient Lift107002019-09-25
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00840117336544LabChoice Plastic Test Tubes, Polystyrene, 12 x 75 mm Dynarex CorporationKJG2025-04-17