| Primary Device ID | B056SCLC5 |
| NIH Device Record Key | 265ef6a5-4f07-48cb-8a09-5b7d5879185c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | S-CRYOLOCK (C) |
| Version Model Number | S-CL (C) |
| Catalog Number | S-CL (CLEAR) |
| Company DUNS | 080129843 |
| Company Name | BIOTECH INCORPORATED |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM | |
| Phone | 1-800-313-7793 |
| BIOTECH@BIODISENO.COM |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B056SCLC0 [Unit of Use] |
| HIBCC | B056SCLC1 [Primary] |
| HIBCC | B056SCLC2 [Package] Contains: B056SCLC1 Package: PK/50 [10 Units] In Commercial Distribution |
| HIBCC | B056SCLC3 [Package] Contains: B056SCLC1 Package: PK/10 [2 Units] In Commercial Distribution |
| HIBCC | B056SCLC5 [Package] Contains: B056SCLC2 Package: BOX/2000 [40 Units] In Commercial Distribution |
| MQK | Labware, Assisted Reproduction |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[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
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-06 |
| Device Publish Date | 2019-04-26 |
| B056CLRCT2 - Cryolock | 2019-06-03 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 |