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Bondek

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
BONDEK FDA UDI
Generic Name
Polyglycolic acid suture FDA UDI
Device Name
Bondek Plus Violet Braided Polyglycolic Acid Size 0 48" Two FX45 Needles Bard FDA UDI
Model / Reference
IPN000887 FDA UDI
Description
Bondek Plus Violet Braided Polyglycolic Acid Size 0 48" Two FX45 Needles Bard FDA UDI

Identifiers

Catalog Number
BON200 FDA UDI
Primary DI / UDI-DI
04026704604678 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Polyglycolic acid suture FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Polyglycolic acid suture

Bondek by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyglycolic acid suture.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 14300b5e-ed07-4574-b756-84c18ee6c984 37 fields · synced May 30, 2026