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Miltex®

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name
Miltex® FDA UDI
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Device Name
27" SZ 4-0 VIOLT PGA ABS C-6 NEEDLE CIR REV CUT FDA UDI
Model / Reference
62512 FDA UDI
Description
27" SZ 4-0 VIOLT PGA ABS C-6 NEEDLE CIR REV CUT FDA UDI

Identifiers

Catalog Number
62512 FDA UDI
Primary DI / UDI-DI
00381780363913 FDA UDI
510(k) Number
K033762 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial 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

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, bioabsorbable, multifilament, non-antimicrobial

Miltex® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K033762 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra LifeSciences Production Corporation

Sources (1)

  • FDA UDI 0f4cf8b4-cbf6-4053-a156-f787f5454ea5 37 fields · synced Jun 9, 2026