SINUSORB® PGA

GUDID 13661522015008

PETERS SURGICAL

Polyester suture, bioabsorbable, multifilament Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial

• Primary Device ID: 13661522015008
• NIH Device Record Key: ed21b0eb-8d28-468a-b608-f831edc65756
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINUSORB® PGA
• Version Model Number: 8123
• Company DUNS: 265741780
• Company Name: PETERS SURGICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661522015001 [Primary]
GS1	13661522015008 [Package]; Contains: 03661522015001; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062366

FDA Product Code

• GAM: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-17
• Device Publish Date: 2020-01-09

On-Brand Devices [SINUSORB® PGA]

• 13661522022105: 8107
• 13661522014964: 8114
• 13661522014957: 8113
• 13661522014902: 8106
• 13661522014896: 8104
• 13661522029241: 8146
• 13661522028282: 8144
• 13661522027278: 8143
• 13661522025069: 8142
• 13661522023102: 8135
• 13661522022976: 8140
• 13661522022969: 8139
• 13661522022952: 8138
• 13661522022945: 8134
• 13661522022877: 8136
• 13661522022709: 8137
• 13661522022129: 8120
• 13661522022112: 8108
• 13661522015107: 8133
• 13661522015091: 8132
• 13661522015084: 8131
• 13661522015077: 8130
• 13661522015060: 8129
• 13661522015053: 8128
• 13661522015046: 8127
• 13661522015039: 8126
• 13661522015022: 8125
• 13661522015015: 8124
• 13661522015008: 8123
• 13661522014995: 8121
• 13661522014988: 8118
• 13661522014971: 8117
• 13661522014940: 8112
• 13661522014933: 8111
• 13661522014926: 8110
• 13661522014919: 8109
• 13661522014889: 8102
• 13661522014872: 8101