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Invenio

FDA UDI

Class II (US FDA UDI)

by Gri-Alleset, Inc.

Identity

Trade Name
Invenio FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Introducer Kit Micro 4fr X 45, cm W/ Nitinol Gw 21G Ndl Echo FDA UDI
Model / Reference
525-037 FDA UDI
Description
Introducer Kit Micro 4fr X 45, cm W/ Nitinol Gw 21G Ndl Echo FDA UDI

Identifiers

Primary DI / UDI-DI
00840365900948 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

Invenio by Gri-Alleset, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gri-Alleset, Inc.

Sources (1)

  • FDA UDI fb4ab18d-42fe-440a-acba-8cc52059ae60 34 fields · synced May 30, 2026