Transem Stylet 19 cm = 24 cm ET

GUDID 20888937972799

Stylet for embryo transfer catheter.

Origio A/S

Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set
Primary Device ID20888937972799
NIH Device Record Key399fe09e-b3ab-45b4-9b9b-554a4340fa65
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransem Stylet 19 cm = 24 cm ET
Version Model NumberTSET1924
Company DUNS305424269
Company NameOrigio A/S
Device Count25
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937972801 [Unit of Use]
GS120888937972799 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQFCatheter, Assisted Reproduction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-01-23
Device Publish Date2018-05-15

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.