Reflex

FDA UDI

Class I (US FDA UDI)

by Conmed Corporation

Identity

Trade Name: REFLEX FDA UDI
Generic Name: Skin stapler/staple, non-bioabsorbable FDA UDI
Device Name: Reflex One, Skin Stapler, 35 regular FDA UDI
Model / Reference: 3036R FDA UDI
Description: Reflex One, Skin Stapler, 35 regular FDA UDI

Identifiers

Catalog Number: 3036R FDA UDI
Primary DI / UDI-DI: 20653405050596 FDA UDI
FDA Product Code: FZQ FDA UDI
QQS FDA UDI
GMDN Term: Skin stapler/staple, non-bioabsorbable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4320 FDA UDI
878.4740 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Skin stapler/staple, non-bioabsorbable

Reflex by Conmed Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin stapler/staple, non-bioabsorbable.

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CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
SkinPlus — Taiwan Surgical Corporation · Class I
TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Multifire Premium — Covidien LP · Class I
WECK — TELEFLEX INCORPORATED · Class I

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: Conmed Corporation

Sources (1)

FDA UDI c6f01d97-5b49-4e72-9d5a-7ae1505e8fbd 36 fields · synced May 30, 2026