PDS Plates ZX5

GUDID 20705031087955

PDS PLATE VIO 0.25X50X40MM RECTANGULAR

ETHICON INC.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: 20705031087955
• NIH Device Record Key: 93187e87-642b-493e-be56-11da4bd2b3cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PDS Plates
• Version Model Number: ZX5
• Catalog Number: ZX5
• Company DUNS: 002144145
• Company Name: ETHICON INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031087958 [Primary]
GS1	20705031087955 [Package]; Contains: 10705031087958; Package: BOX [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092590

FDA Product Code

• NHB: POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-21
• Device Publish Date: 2017-06-14

On-Brand Devices [PDS Plates]

• 20705031087986: PDS PLATE VIO 0.5X50X40MM RECTANGULAR
• 20705031087962: PDS PLATE VIO 0.25X50X40MM RECTANGULAR
• 20705031132532: PDS FLEX PLATE 0.15X50X40MM PERFORATED NASAL IMPLANT
• 20705031132525: PDS FLEX PLATE 0.50X40X50MM NASAL IMPLANT
• 20705031132518: PDS FLEX PLATE 0.25X40X50MM NASAL IMPLANT
• 20705031088006: PDS PLATE VIO 0.15X50X40MM RECTANGULAR PERFORATED
• 20705031087993: PDS PLATE VIO 0.15X30X40MM SHAPED PERFORATED
• 10705031087989: PDS PLATE VIO 0.5X50X40MM RECTANGULAR
• 20705031087979: PDS PLATE VIO 0.5X50X40MM RECTANGULAR
• 10705031087965: PDS PLATE VIO 0.25X50X40MM RECTANGULAR
• 20705031087955: PDS PLATE VIO 0.25X50X40MM RECTANGULAR
• 20705031087948: PDS PLATE VIO 0.5X30X40MM SHAPED
• 20705031087931: PDS PLATE VIO 0.25X30X40MM SHAPED