FDA.reportPublic FDA data

CRYOPETTE

Primary DI
20888937900129
Brand
CRYOPETTE
Company
ORIGIO INC.
Model
CRY-PETTE-RED
Device description
CRYOPETTE
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937900129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088893790012920888937900129

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction vitrification carrierA sterile, plastic device used during an assisted reproduction vitrification (cryopreservation) procedure to hold a small volume of vitrification media containing a biological specimen (e.g., egg, embryo) to vitrify (cryopreserve) the specimen, thereby avoiding specimen immersion/contact with LN2. The vitrification process may involve the distal tip/specimen being brought into contact with the surface of a vitrification block [a highly-conductive mass of metal semi-submersed in a liquid nitrogen (LN2) bath]. The device with vitrified specimen is then stored in an LN2 tank, and subsequently transferred into a warming medium to recover the specimen. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787068394
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937907834N/AMXL3-PLG-PGD2016-08-22
00888937907872STRIPPERMXL3-STR2016-08-22
00888937907889N/AMXL3-STR-BP-DE2016-08-22
00888937907902N/AMXL3-STR-BP-SW2016-08-22
00888937907919STRIPPERMXL3-STR-CC2016-08-22
00888937907926STRIPPERMXL3-STR-CGR2016-08-22
00888937907933STRIPPERMXL3-STR-PGD2016-08-22
00888937907940STRIPPERMXL3-STR-PGD-CG2016-08-22
20888937906220STRIPPER MXL3-1002016-08-22
20888937906237STRIPPER MXL3-1252016-08-22
20888937906244STRIPPER MXL3-1352016-08-22
20888937906251STRIPPER MXL3-1502016-08-22
20888937906268STRIPPER MXL3-1752016-08-22
20888937906275STRIPPER MXL3-2002016-08-22
20888937906282STRIPPER MXL3-502016-08-22
20888937906299STRIPPER MXL3-6002016-08-22
20888937906305STRIPPER MXL3-752016-08-22
20888937906312STRIPPERMXL3-CC2016-08-22
20888937906329STRIPPERMXL3-IND-1002016-08-22
20888937906336STRIPPERMXL3-IND-1252016-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B056CLRCTLG2CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056SCLLG2S-CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
00810195240002cryo-GO Vitrification Device - Red (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
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
00810195240033cryo-GO Vitrification Device - Green (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240040cryo-GO Vitrification Device - Purple (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240057cryo-GO Vitrification Device - Red (Pack of 50)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240064cryo-GO Vitrification Device - Yellow (Pack of 50)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240071cryo-GO Vitrification Device - Blue (Pack of 50)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240088cryo-GO Vitrification Device - Green (Pack of 50)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240095cryo-GO Vitrification Device - Purple (Pack of 50)IRVINE SCIENTIFIC, LLCMQK2025-06-02
24719874742267LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-04-10
25070002516204SpermAlignCYTOSWIM LTDMQK2025-03-03
14719874742222LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
14719874742239LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
14719874742253LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
14719874742284LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
24719874742229LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
24719874742236LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
24719874742250LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
24719874742281LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
00857515006658cryo-GO Vitrification DeviceFUJIFILM IRVINE SCIENTIFIC, INC.MQK2024-10-23