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
CLOSE

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
Polypropylene suture A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of polypropylene, an isostatic crystalline stereoisomer of a linear propylene polymer, intended to join (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; as the material does not adhere to tissues, it is typically used in cases where the suture is to be removed after healing. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GAW Suture, Nonabsorbable, Synthetic, Polypropylene
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P890002 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 8 Inch
CLOSE

Device Record Status

971905b4-4d3e-4b25-930d-98971607193f
July 06, 2018
3
October 24, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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