FDA.reportPublic FDA data

Cryotec

Primary DI
04589700010015
Brand
Cryotec
Company
REPROLIFE INC.
Model
TEC010B
Catalog number
TEC010B
Device description
Cryotec (10 pieces) (Blue)
Published
2017-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQKLabware, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQKLabware, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162051000CryotecReprolife, Inc.2016-12-14MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589700010015PrimaryGS10
00045897000101Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
04589700010015045897000100154589700010015
00045897000101000458970001010458970001010045897000101

GMDN Terms#

Term, Definition table
TermDefinition
Tissue storage strawA long, thin, tubular sterile device in the form of a straw used for the placement and storage of human biological samples such as embryos, oocytes, sperm, and human tissue in liquid nitrogen (LN2) or in the volumes of vapour phase LN2 in a liquid nitrogen container. It is made of materials to withstand storage in LN2 and is available in a variety of designs that may include a sliding plug or a permeable membrane plug to hold the sample. The sample is inserted into one end of the device and both ends are sealed, typically by using a thermal sealing device, creating an airtight seal to protect the sample from direct contact with the LN2. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius20 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius20 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
691176883
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589700010404Vitri PlateVP0102019-07-12
04589700010411Warm PlateWP0102019-07-12
04589700010022CryotecTEC010RTEC010R2017-08-31
04589700010039CryotecTEC010YTEC010Y2017-08-31
04589700010046CryotecTEC010GTEC010G2017-08-31
04589700010053CryotecTEC010WTEC010W2017-08-31
04589700010060CryotecTEC110BTEC110B2017-08-31
04589700010077CryotecTEC110RTEC110R2017-08-31
04589700010084CryotecTEC110YTEC110Y2017-08-31
04589700010091CryotecTEC110GTEC110G2017-08-31
04589700010107CryotecTEC110WTEC110W2017-08-31
04589700010114CryotecTEC004BTEC004B2017-08-31
04589700010121CryotecTEC004RTEC004R2017-08-31
04589700010138CryotecTEC004YTEC004Y2017-08-31
04589700010145CryotecTEC004GTEC004G2017-08-31
04589700010152CryotecTEC004WTEC004W2017-08-31
04589700010169CryotecTEC104BTEC104B2017-08-31
04589700010176CryotecTEC104RTEC104R2017-08-31
04589700010183CryotecTEC104YTEC104Y2017-08-31
04589700010190CryotecTEC104GTEC104G2017-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888937029079LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029086LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029093LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029109LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
06971855770308Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770315Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770322Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770339Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770377Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
00888937027945ZyMotCoopersurgical, Inc.MQK2026-01-23
00888937027952ZyMotCoopersurgical, Inc.MQK2026-01-23
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20888937025860PICSI®Coopersurgical, Inc.MQK2025-10-20
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00810195240019cryo-GO Vitrification Device - Yellow (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240026cryo-GO Vitrification Device - Blue (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02