DEVICE: A.C.S® (Alcon Closure System) (00380652115018)

Device Identifier (DI) Information

A.C.S® (Alcon Closure System)
8065211501
In Commercial Distribution

Alcon Laboratories, Inc.
00380652115018
GS1

1
008018525 *Terms of Use
Suture - Needle Type R-1,Black Monofilament Nylon(BMN), 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
Nylon suture, monofilament A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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 can be removed from the tissue once wound healing occurs or allowed to remain in the tissue where it is gradually encapsulated by fibrous connective tissue. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GAR Suture, Nonabsorbable, Synthetic, Polyamide
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K930517 000
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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

76eeeb95-2712-42a9-8936-2472720e4d71
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
10380652115015 12 00380652115018 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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