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DemeBOND

FDA UDI

Class II (US FDA UDI)

by DemeTECH Corp

Identity

Trade Name
DemeBOND FDA UDI
Generic Name
Polyester suture, non-bioabsorbable, multifilament FDA UDI
Device Name
Polyester Multifilament Coated,Braided, Sterile, Nonabsorbable Suture FDA UDI
Model / Reference
PB1040035B6P FDA UDI
Description
Polyester Multifilament Coated,Braided, Sterile, Nonabsorbable Suture FDA UDI

Identifiers

Primary DI / UDI-DI
10652927270263 FDA UDI
510(k) Number
K023030 FDA UDI
FDA Product Code
GAT FDA UDI
GMDN Term
Polyester suture, non-bioabsorbable, multifilament FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5000 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: Polyester suture, non-bioabsorbable, multifilament

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

Similar devices

Also classified as Polyester suture, non-bioabsorbable, multifilament.

Cleared under the same submission

K023030 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 893a2143-8f17-4ee3-80e8-6377b951c12d 36 fields · synced May 29, 2026