DEVICE: A.C.S® (Alcon Closure System) (00380652112017)

Device Identifier (DI) Information

A.C.S® (Alcon Closure System)
8065211201
In Commercial Distribution

Alcon Laboratories, Inc.
00380652112017
GS1

1
008018525 *Terms of Use
Suture - Needle Type R-1,Green Braided Polyester(GBP), Suture Size 5-0, Suture Length 18,Double Armed
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Polyester suture A sterile, multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of polyester (a polymer of polyethylene terephthalate) fibres, that may be coated (e.g., with polybutilate/silicone), intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may also include an attached disposable needle or preloaded pledget for enhanced support. It is commonly used for vessel anastomosis and the placement of prosthetic materials, and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it elicits minimal tissue reaction and lasts indefinitely in the body. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GAS Suture, Nonabsorbable, Synthetic, Polyester
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P880094 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 18 Inch
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Device Record Status

7be59356-103f-4182-80ef-4d491a1602e2
July 06, 2018
3
October 24, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10380652112014 12 00380652112017 In Commercial Distribution BOX
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1 (800 241-5999
web.masterus@alcon.com
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