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Surgilon

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Surgilon FDA UDI
Generic Name
Nylon suture, non-bioabsorbable, multifilament FDA UDI
Device Name
Braided Nylon FDA UDI
Model / Reference
88861971-61 FDA UDI
Description
Braided Nylon FDA UDI

Identifiers

Primary DI / UDI-DI
10884521073401 FDA UDI
510(k) Number
K981582 FDA UDI
FDA Product Code
GAR FDA UDI
GMDN Term
Nylon suture, non-bioabsorbable, multifilament FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5020 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 30 Inch FDA UDI

Category: Nylon suture, non-bioabsorbable, multifilament

Surgilon by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K981582 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 34b3e965-97e4-4ce7-b705-884e0c26c2ce 37 fields · synced Jun 8, 2026