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 Bariatric Length (12mm - 2 Holes) - Reusable FDA UDI
Model / Reference: PMISG12B2 FDA UDI
Description: PMI Suture Guide Bariatric Length (12mm - 2 Holes) - Reusable FDA UDI

Identifiers

Catalog Number: PMISG12B2 FDA UDI
Primary DI / UDI-DI: 00812608020256 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

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

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Also classified as Needle guide, reusable.

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InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Duckworth & Kent — DUCKWORTH AND KENT LIMITED · Class I
MP-2794-G16 — FUJIFILM Corporation · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Progressive Medical, Inc.

Sources (1)

FDA UDI 1807dedb-fd2d-4736-bcd5-7ba178979ffd 34 fields · synced May 31, 2026