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Gen2

FDA UDI

Class I (US FDA UDI)

by Surgix Medical Llc

Identity

Trade Name
GEN2 FDA UDI
Generic Name
Exploratory blunt needle, reusable FDA UDI
Device Name
HEPARIN NEEDLE W/OLIVE TIP FDA UDI
Model / Reference
G2G36952 FDA UDI
Description
HEPARIN NEEDLE W/OLIVE TIP FDA UDI

Identifiers

Catalog Number
G2G36952 FDA UDI
Primary DI / UDI-DI
00840343722203 FDA UDI
FDA Product Code
KBR FDA UDI
GMDN Term
Exploratory blunt needle, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Exploratory blunt needle, reusable

Gen2 by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exploratory blunt needle, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgix Medical Llc

Sources (1)

  • FDA UDI 8917fbd2-b9de-468a-95a9-4a7d8b58a4fe 35 fields · synced Jun 8, 2026