DEVICE: A.C.S® (Alcon Closure System), PAIR-PAK II® (00380653052015)

Device Identifier (DI) Information

A.C.S® (Alcon Closure System), PAIR-PAK II®
8065305201
In Commercial Distribution

Alcon Laboratories, Inc.
00380653052015
GS1

1
008018525 *Terms of Use
"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"
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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.
Silk suture, sterile A sterile, natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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 disposable needle. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K760158 000
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: 12 Inch
Length: 8 Inch
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Device Record Status

192cf92f-f6d0-4e5d-885c-2709415c96c1
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
10380653052012 12 00380653052015 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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