Syringe with fixed needle - For use only with GONA BS-N1A2713U6

GUDID 55413206214162

Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH

Terumo Europe NV

Metered-delivery hypodermic syringe
Primary Device ID55413206214162
NIH Device Record Key0af10f76-2e8b-42fa-9d57-da5b8805320b
Commercial Distribution Discontinuation2018-06-19
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSyringe with fixed needle - For use only with GONA
Version Model NumberBS-N1A2713U6
Catalog NumberBS-N1A2713U6
Company DUNS370193559
Company NameTerumo Europe NV
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 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

Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedica

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge27 Gauge

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity.

Device Identifiers

Device Issuing AgencyDevice ID
GS105413206214167 [Primary]
GS135413206214168 [Package]
Contains: 05413206214167
Package: Plastic Box [6 Units]
Discontinued: 2018-06-19
Not in Commercial Distribution
GS155413206214162 [Package]
Contains: 35413206214168
Package: Carton [120 Units]
Discontinued: 2018-06-19
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-03-15

On-Brand Devices [Syringe with fixed needle - For use only with GONA]

55413206220248Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/ml FSH
55413206214209Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH
55413206214162Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH

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