Syndex with Constrictor® Technology

FDA UDI

Class II (US FDA UDI)

by Dunamis Medical LLC

Identity

Trade Name: Syndex with Constrictor® Technology FDA UDI
Generic Name: Orthopaedic fixation suture button FDA UDI
Device Name: Syndex with Constrictor® Technology for Syndesmosis Repair FDA UDI
Model / Reference: MSYN0000 FDA UDI
Description: Syndex with Constrictor® Technology for Syndesmosis Repair FDA UDI

Identifiers

Catalog Number: MSYN0000 FDA UDI
Primary DI / UDI-DI: 00854629006727 FDA UDI
FDA Product Code: HTN FDA UDI
MBI FDA UDI
HTW FDA UDI
GMDN Term: Orthopaedic fixation suture button FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 FDA UDI
888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Fluted surgical drill bit, single-use Orthopaedic fixation suture button

Syndex with Constrictor® Technology by Dunamis Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic fixation suture button.

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Arthrex® — Arthrex, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
ProCinch, Slotted Button, Concave Round 11mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class II
Arthrex® — Arthrex, Inc. · 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 II	Pending data

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Manufacturer

Manufacturer: Dunamis Medical LLC

Sources (1)

FDA UDI 63f8a416-9451-4e96-94b1-15388501a7b2 35 fields · synced May 30, 2026