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

FDA UDI

Class II (US FDA UDI)

by Terumo Europe NV

Identity

Trade Name
Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH FDA UDI
Generic Name
Metered-delivery hypodermic syringe FDA UDI
Device Name
Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH FDA UDI
Model / Reference
BS-N1A2713U10 FDA UDI
Description
Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH FDA UDI

Identifiers

Catalog Number
BS-N1A2713U10 FDA UDI
Primary DI / UDI-DI
05413206214204 FDA UDI
510(k) Number
K161606 FDA UDI
FDA Product Code
FMF FDA UDI
GMDN Term
Metered-delivery hypodermic syringe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 27 Gauge FDA UDI

Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH by Terumo Europe NV — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K161606 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Terumo Europe NV

Sources (1)

  • FDA UDI f272a677-f744-41b6-ad9a-9b05bfadeb2c 39 fields · synced May 31, 2026