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 AU-1, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 8" / "Suture 2 - Needle Type PC-5, Black Braided Silk(BBS), Suture Size 4-0, Suture Lenght 12" FDA UDI
- Model / Reference
- 8065305201 FDA UDI
- Description
- "Suture 1 - Needle Type AU-1, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 8" / "Suture 2 - Needle Type PC-5, Black Braided Silk(BBS), Suture Size 4-0, Suture Lenght 12" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380653052015 FDA UDI
- FDA Product Code
- GAR FDA UDIGAP FDA UDI
- GMDN Term
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5020 FDA UDI878.5030 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
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 — 12 Inch FDA UDILength — 8 Inch FDA UDI
Category: Nylon suture, non-bioabsorbable, monofilamentSilk suture
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
Similar devices
Also classified as Silk suture.
- Sofsilk — Covidien LP · Class II
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- DemeSILK — DemeTECH Corp · Class II
- DemeSILK — DemeTECH Corp · Class II
- DemeSILK — DemeTECH Corp · Class II
- Sofsilk — Covidien LP · Class II
- DemeSILK — DemeTECH Corp · Class II
- DemeSILK — DemeTECH Corp · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI 192cf92f-f6d0-4e5d-885c-2709415c96c1 35 fields · synced May 30, 2026