Biopsy Medium

GUDID 00888937800654

Biopsy Medium. 10 ml

Origio A/S

IVF medium
Primary Device ID00888937800654
NIH Device Record Keyd280f4e9-f2f9-4a76-8534-cda8f8ed055e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiopsy Medium
Version Model Number10620010D
Company DUNS305424269
Company NameOrigio A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937800654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-22

Devices Manufactured by Origio A/S

60888937027138 - SAGE Vitrification Warming Kit XL2022-12-01 SAGE Vitrification Warming Kit , ART-8034 (in plastic cryo vials): 8x2 ml of 1,0 M ART-8031-A Sucrose Warming Solution. 2x2 ml o
00888937833027 - SynVitro Hyadase2021-01-26 SynVitro Hyadase. 5x1 ml
00888937819342 - CSC Freezing Medium2019-09-12 CSC Freezing Medium - Choline Substituted Cryopreservation Freezing Medium. 10 ml
00888937801491 - EmbryoAssist2019-08-29 EmbryoAssist. 10 ml
00888937833058 - SAGE 1-Step2019-03-11 Sage 1-Step GM-CSF with HSA. 3 ml
00888937833072 - SAGE 1-Step2019-03-11 SAGE 1-Step GM-CSF with SPS. 3 ml.
20888937972348 - Transem Spherical 2019-01-23 Embryo transfer catheter, spherical tip.
20888937972355 - EchoGen Spherical 2019-01-23 Embryo transfer catheter, echogenic/spherical. 24 cm

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