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DemeSTEEL

FDA UDI

Class II (US FDA UDI)

by DemeTECH Corp

Identity

Trade Name
DemeSTEEL FDA UDI
Generic Name
Metallic suture, monofilament FDA UDI
Device Name
Stainless Steel Surgical Non Absorbable Suture FDA UDI
Model / Reference
SW4X110448B0P FDA UDI
Description
Stainless Steel Surgical Non Absorbable Suture FDA UDI

Identifiers

Primary DI / UDI-DI
10652927430179 FDA UDI
510(k) Number
K141007 FDA UDI
FDA Product Code
GAQ FDA UDI
GMDN Term
Metallic suture, monofilament FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4495 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

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Metallic suture, monofilament

DemeSTEEL by DemeTECH Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic suture, monofilament.

Cleared under the same submission

K141007 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DemeTECH Corp

Sources (1)

  • FDA UDI 59d5b9b2-6c6b-46e5-a41b-7f304a3b598b 36 fields · synced Jun 8, 2026