S-CRYOLOCK (C) S-CL (CLEAR)

GUDID B056SCLC5

S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

BIOTECH INCORPORATED

Assisted reproduction vitrification carrier
Primary Device IDB056SCLC5
NIH Device Record Key265ef6a5-4f07-48cb-8a09-5b7d5879185c
Commercial Distribution StatusIn Commercial Distribution
Brand NameS-CRYOLOCK (C)
Version Model NumberS-CL (C)
Catalog NumberS-CL (CLEAR)
Company DUNS080129843
Company NameBIOTECH INCORPORATED
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM
Phone1-800-313-7793
EmailBIOTECH@BIODISENO.COM

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB056SCLC0 [Unit of Use]
HIBCCB056SCLC1 [Primary]
HIBCCB056SCLC2 [Package]
Contains: B056SCLC1
Package: PK/50 [10 Units]
In Commercial Distribution
HIBCCB056SCLC3 [Package]
Contains: B056SCLC1
Package: PK/10 [2 Units]
In Commercial Distribution
HIBCCB056SCLC5 [Package]
Contains: B056SCLC2
Package: BOX/2000 [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQKLabware, Assisted Reproduction

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


[B056SCLC5]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-06
Device Publish Date2019-04-26

Devices Manufactured by BIOTECH INCORPORATED

B056CLRCT2 - Cryolock2019-06-03 Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage
B056SCLB5 - S-CRYOLOCK (B)2019-05-06 S-CRYOLOCK - BLUE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain
B056SCLC5 - S-CRYOLOCK (C)2019-05-06S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
B056SCLC5 - S-CRYOLOCK (C)2019-05-06 S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintai
B056SCLG5 - S-CRYOLOCK (G)2019-05-06 S-CRYOLOCK - GREEN - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintai
B056SCLO5 - S-CRYOLOCK (O)2019-05-06 S-CRYOLOCK - ORANGE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and mainta
B056SCLY5 - S-CRYOLOCK (Y)2019-05-06 S-CRYOLOCK - YELLOW - Cryopreservation storage device that is intended for use in vitrification procedures to contain and mainta
B056CLRCTB2 - Cryolock(B)2018-07-06 Cryolock - Blue Cryopreservation Storage Device that is intended for use in vitrification procedures to contain and maintain hum
B056CLRCTC5 - CRYOLOCK(C)2018-07-06 Cryolock - Clear Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain hu

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