NuStat Flex XR

FDA UDI

Class U (US FDA UDI)

by Beeken Biomedical

Identity

Trade Name: NuStat Flex XR FDA UDI
Generic Name: Wound dressing kit, non-medicated FDA UDI
Device Name: 3X48 FDA UDI
Model / Reference: XR-3000097317 FDA UDI
Description: 3X48 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850392006537 FDA UDI
510(k) Number: K160578 FDA UDI
FDA Product Code: FRO FDA UDI
GMDN Term: Wound dressing kit, non-medicated FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Wound dressing kit, non-medicated

NuStat Flex XR by Beeken Biomedical — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Wound dressing kit, non-medicated.

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Cleared under the same submission

K160578 also covers:

NuStat — Beeken Biomedical
NuStat — Beeken Biomedical
NuStat Flex — Beeken Biomedical
NuStat Flex XR — Beeken Biomedical
NuStat Flex XR — Beeken Biomedical
NuStat Flex XR — Beeken Biomedical
NuStat Trauma Pad — Beeken Biomedical
NuStat Trauma Pad XR — Beeken Biomedical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Beeken Biomedical

Sources (1)

FDA UDI 446c0540-2ef1-498e-8f30-37a2c62556c4 34 fields · synced May 30, 2026