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Pds

FDA UDI

Class II (US FDA UDI)

by Ethicon Inc.

Identity

Trade Name
PDS FDA UDI
Generic Name
Polyester suture, bioabsorbable, monofilament, antimicrobial FDA UDI
Device Name
Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture FDA UDI
Model / Reference
PDP347H FDA UDI
Description
Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture FDA UDI

Identifiers

Catalog Number
PDP347H FDA UDI
Primary DI / UDI-DI
10705031048133 FDA UDI
510(k) Number
K061037 FDA UDI
K212380 FDA UDI
FDA Product Code
NEW FDA UDI
GMDN Term
Polyester suture, bioabsorbable, monofilament, antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4840 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

Yes

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, bioabsorbable, monofilament, antimicrobial

Pds by Ethicon Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyester suture, bioabsorbable, monofilament, antimicrobial.

Cleared under the same submission

K061037 also covers:

K212380 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ethicon Inc.

Sources (1)

  • FDA UDI a9d54e21-1917-47f6-8434-3fdb191495d3 36 fields · synced May 30, 2026