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Gimmi

FDA UDI

Class I (US FDA UDI)

by Gimmi GmbH

Identity

Trade Name
Gimmi FDA UDI
Generic Name
Pericardiocentesis needle, reusable FDA UDI
Device Name
SHEA NEEDLE SHARP LENGTH 160 MM FDA UDI
Model / Reference
QO.2297.00 FDA UDI
Description
SHEA NEEDLE SHARP LENGTH 160 MM FDA UDI

Identifiers

Catalog Number
QO.2297.00 FDA UDI
Primary DI / UDI-DI
04049047715474 FDA UDI
FDA Product Code
JYT FDA UDI
GMDN Term
Pericardiocentesis 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Pericardiocentesis needle, reusable

Gimmi by Gimmi GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pericardiocentesis needle, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gimmi GmbH

Sources (1)

  • FDA UDI 1a83a7b7-ab02-42a7-8c06-8150b6565131 35 fields · synced May 29, 2026