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Sutumed

FDA UDI

Class II (US FDA UDI)

by Unilene Sac

Identity

Trade Name
SUTUMED FDA UDI
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Device Name
POLYGLACTIN FDA UDI
Model / Reference
SDAG060QE080 FDA UDI
Description
POLYGLACTIN FDA UDI

Identifiers

Catalog Number
SDAG060QE080 FDA UDI
Primary DI / UDI-DI
07757093002956 FDA UDI
510(k) Number
K100780 FDA UDI
FDA Product Code
GAN FDA UDI
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4830 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

No

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

Yes

FDA UDI
Sterilization Method
Dry Heat Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 080 Gauge FDA UDI

Category: Polyester suture, bioabsorbable, multifilament, non-antimicrobialSurgical support tape, bioabsorbable

Sutumed by Unilene Sac — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical support tape, bioabsorbable.

Cleared under the same submission

K100780 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Unilene Sac

Sources (1)

  • FDA UDI 47c20d51-7eb5-4941-9c1d-589143cddc71 38 fields · synced May 30, 2026