FDA.reportPublic FDA data

LabChoice Cryogenic Tubes, With Graduated Markings, 5mL, Sterile

Primary DI
00840117337329
Brand
LabChoice Cryogenic Tubes, With Graduated Markings, 5mL, Sterile
Company
Dynarex Corporation
Model
42401
Device description
STERILE-R
Published
2025-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FMHContainer, Specimen, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117335073PackageGS14In Commercial Distribution
00840117337329PrimaryGS10
00810180841276Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117335073008401173350738401173350730840117335073
00840117337329008401173373298401173373290840117337329
00810180841276008101808412768101808412760810180841276

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction cryotubeA sterile container (a dedicated sealable tube) intended for transport, storage and preparation of biological samples of human origin used in assisted reproduction techniques (ART), e.g., embryos. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in, in vitro fertilization (IVF) and ART clinics. Its main application being to hold biological materials when stored in a frozen state at temperatures below -130 Celsius (e.g., stored in the gas phase above the liquid nitrogen (LN2) at temperatures around -178 C to -150 C). This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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00616784351612Heavy Duty Fitted Cot Sheet, White, 30" x 73"35162021-09-01
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00616784369228Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd36922021-09-01
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00616784369426Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd36942021-09-01
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