FDA-Device2018-08-01Class II

PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)

Ethicon, Inc.
Hazard

Products do not meet a tensile strength specification

Sold states
Japan
Affected count
4992
Manufactured in
Us Highway 22 West, N/A, Somerville, NJ, United States
Products
PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2532-2018

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