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Pmi

FDA UDI

Class I (US FDA UDI)

by Progressive Medical, Inc.

Identity

Trade Name
PMI FDA UDI
Generic Name
Needle guide, reusable FDA UDI
Device Name
PMI Suture Guide (10/12mm) - Reusable FDA UDI
Model / Reference
PMISG10 FDA UDI
Description
PMI Suture Guide (10/12mm) - Reusable FDA UDI

Identifiers

Catalog Number
PMISG10 FDA UDI
Primary DI / UDI-DI
00812608020232 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Needle guide, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Needle guide, reusable

Pmi by Progressive Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Needle guide, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Progressive Medical, Inc.

Sources (1)

  • FDA UDI 6fe58d74-02ef-43e5-a7a7-360289bd59a9 35 fields · synced May 30, 2026