← Back to catalogue

A.C.S® (Alcon Closure System)

FDA UDI

Class II (US FDA UDI)

by Alcon Laboratories, Inc.

Identity

Trade Name
A.C.S® (Alcon Closure System) FDA UDI
Generic Name
Polyester suture, non-bioabsorbable, multifilament FDA UDI
Device Name
Suture - Needle Type R-1,White Braided Polyester(WBP), Suture Size 5-0, Suture Length 18,Double Armed FDA UDI
Model / Reference
8065211101 FDA UDI
Description
Suture - Needle Type R-1,White Braided Polyester(WBP), Suture Size 5-0, Suture Length 18,Double Armed FDA UDI

Identifiers

Primary DI / UDI-DI
00380652111010 FDA UDI
PMA Number
P880094 FDA UDI
FDA Product Code
GAS FDA UDI
GMDN Term
Polyester suture, non-bioabsorbable, multifilament FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5000 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

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 18 Inch FDA UDI

Category: Polyester suture, non-bioabsorbable, multifilament

A.C.S® (Alcon Closure System) by Alcon Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

P880094 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alcon Laboratories, Inc.

Sources (1)

  • FDA UDI bf07fb21-3858-47eb-8c6f-6aabf01f6a85 36 fields · synced May 30, 2026