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A.C.S® (Alcon Closure System), PAIR-PAK II®

FDA UDI

Class II (US FDA UDI)

by Alcon Laboratories, Inc.

Identity

Trade Name
A.C.S® (Alcon Closure System), PAIR-PAK II® FDA UDI
Generic Name
Nylon suture, non-bioabsorbable, monofilament FDA UDI
Device Name
Suture 1 - Needle Type CU-1, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12" / Suture 2 - Needle Type PC-5, Black Braided Silk(BBS), Suture Size 4-0, Suture Lenght 30" FDA UDI
Model / Reference
8065307201 FDA UDI
Description
Suture 1 - Needle Type CU-1, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12" / Suture 2 - Needle Type PC-5, Black Braided Silk(BBS), Suture Size 4-0, Suture Lenght 30" FDA UDI

Identifiers

Primary DI / UDI-DI
00380653072013 FDA UDI
FDA Product Code
GAR FDA UDI
GAP FDA UDI
GMDN Term
Nylon suture, non-bioabsorbable, monofilament FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5020 FDA UDI
878.5030 FDA UDI
Commercial Distribution
Not 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

Yes

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 — 30 Inch FDA UDI
Length — 12 Inch FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alcon Laboratories, Inc.

Sources (1)

  • FDA UDI 3e4efb5f-80ae-4124-8ac7-14d6873e4e87 36 fields · synced Jun 6, 2026