Unolok

FDA UDI

Class II (US FDA UDI)

by Hindustan Syringes And Medical Devices Limited

Identity

Trade Name: UNOLOK FDA UDI
Generic Name: Venous butterfly needle/set FDA UDI
Device Name: UNOLOK Luer Lock Infusion Set,21 G X ¾" ( 0.80X19MM) 12" TUBE MYCO RE-ORDER # 7001-21 FDA UDI
Model / Reference: 21 G X ¾" FDA UDI
Description: UNOLOK Luer Lock Infusion Set,21 G X ¾" ( 0.80X19MM) 12" TUBE MYCO RE-ORDER # 7001-21 FDA UDI

Identifiers

Catalog Number: 00326 FDA UDI
Primary DI / UDI-DI: 08903347003265 FDA UDI
510(k) Number: K953252 FDA UDI
FDA Product Code: FOZ FDA UDI
GMDN Term: Venous butterfly needle/set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5200 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: Venous butterfly needle/set

Unolok by Hindustan Syringes And Medical Devices Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K953252 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Hindustan Syringes And Medical Devices Limited

Sources (1)

FDA UDI 19f0c502-6cce-41c6-baea-5191f64d658e 35 fields · synced May 30, 2026