FDA.report

CBS STERILE FILLING NOZZLE - BOX 100

Primary DI
03661532002947
Company
CRYO BIO SYSTEM
Model
1
Catalog number
024856
Published
2020-10-30
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

Related Records

Regulatory Flags

DUNS number
500731872
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
03661532002947PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
03661532002947PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MQKLabware, Assisted Reproduction2Obstetrics/Gynecology884.6160NEligible

Premarket Submissions

SubmissionSupplement
K002595000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K002595000CBS STRAWCryo Bio System2000-11-17MQG

GMDN Terms

TermDefinition
Tissue cryostorage straw vitrification setA collection of sterile devices designed for use in the vitrification process and cryopreservation 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 typically consists of a tissue storage straw, a curved spatula or capillary tube (used for the capture of the specimen) which may be colour-coded, and an insertion device for positioning of the spatula or capillary tube with the specimen into the tissue collection straw. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03661532002077STERILE CBS HIGH SECURITY TISSUE 2 ML STRAW / BY 2010189602020-12-07
03661532000301STERILE CBS 0.3ML STRAW FOR SPERM WITHOUT JACKET WHITE PLUG - 4X510102872020-10-30
03661532000325STERILE CBS 0.3 ML STRAW FOR SPERM WITHOUT JACKET WITH WHITE PLUG - 5x2010102882020-10-30
03661532000332STERILE CBS 0.5 ML STRAW FOR SPERM WITH COTTON PLUG / 5 x 2010146502020-10-30
03661532002626 CBS Non-Sterile High Security Tube 10222512020-10-30
03661532002633CBS STERILE HIGH SECURITY TUBE BY 20 UNITS10222522020-10-30
03661532002657CBS STERILE HIGH SECURITY TUBE BY 50 UNITS10237222020-10-30
03661532002954CBS HIGH SECURITY EMBRYO AND SPERM STRAW/5x4x110252922020-10-30
03661532002985BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - YELLOW10252482020-10-30
03661532002992BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - PINK10252492020-10-30
03661532003005BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - BLUE10252502020-10-30
03661532003012BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - GREEN10252512020-10-30
03661532003067CBS INTEGRAL FREEZER20278072020-10-30
03661532003159NANO DIGITCOOL FREEZER20256802020-10-30
03661532002961BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - RED10252462020-10-29
03661532002978BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - WHITE10252472020-10-29

Other Devices Sharing Product Codes

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