DEVICE: A.C.S® (Alcon Closure System) (00380653079012)

Device Identifier (DI) Information

A.C.S® (Alcon Closure System)
8065307901
In Commercial Distribution

Alcon Laboratories, Inc.
00380653079012
GS1

1
008018525 *Terms of Use
Suture - Needle Type PC-9,Blue Polypropylene(PPN), Suture Size 10-0, Suture Length 8,Looped
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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
Polyolefin suture, monofilament A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.
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FDA Product Code

[?]
Product Code Product Code Name
GAW Suture, Nonabsorbable, Synthetic, Polypropylene
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P890002 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: 8 Inch
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Device Record Status

971905b4-4d3e-4b25-930d-98971607193f
February 07, 2019
4
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
10380653079019 12 00380653079012 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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