AccessGUDID - DEVICE: Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/ml FSH (05413206220243)

GUDID

Device Identifier (DI) Information

Brand Name: Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/ml FSH
Version or Model: BS-N1A2713U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BS-N1A2713U
Company Name: Terumo Europe NV

Primary DI Number: 05413206220243
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 370193559 *Terms of Use

Device Description: Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/ml FSH

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35904	Metered-delivery hypodermic syringe	A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161606	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Syringe Volume: 1 Milliliter
Device Size Text, specify: Needle Length: 12 Millimeter
Device Size Text, specify: Needle Outer Diameter: 0.4 Millimeter
Device Size Text, specify: Needle Length: 0.5 Inch
Needle Gauge: 27 Gauge
Device Size Text, specify: Regular wall

Device Record Status

Public Device Record Key: f59ff42c-e545-4cd6-b90e-d217ff767179
Public Version Date: September 05, 2022
Public Version Number: 4
DI Record Publish Date: September 26, 2017