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Gertie Marx Spinal N

FDA UDI

Class II (US FDA UDI)

by International Medical Development Corporation

Identity

Trade Name
GERTIE MARX SPINAL N FDA UDI
Generic Name
Spinal needle, single-use FDA UDI
Device Name
SPINAL NEEDLE FDA UDI
Model / Reference
GM25160175 FDA UDI
Description
SPINAL NEEDLE FDA UDI

Identifiers

Primary DI / UDI-DI
B274GM251601750 FDA UDI
510(k) Number
K070354 FDA UDI
FDA Product Code
BSP FDA UDI
GMDN Term
Spinal needle, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5150 FDA UDI
Commercial Distribution
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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Spinal needle, single-use

Gertie Marx Spinal N by International Medical Development Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal needle, single-use.

Cleared under the same submission

K070354 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
International Medical Development Corporation

Sources (1)

  • FDA UDI d256ec38-fcbc-415c-bdf6-bba276b98249 34 fields · synced Jun 8, 2026