MONO-DOX M398

GUDID 20790986001156

C.P. MEDICAL CORPORATION

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 20790986001156
• NIH Device Record Key: 6a928acc-2959-4203-b9c5-6efff466c0bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONO-DOX
• Version Model Number: M398
• Catalog Number: M398
• Company DUNS: 807404611
• Company Name: C.P. MEDICAL CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10790986001159 [Primary]
GS1	20790986001156 [Package]; Contains: 10790986001159; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013274

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

Sterilization

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

[20790986001156]

Ethylene Oxide

[20790986001156]

Ethylene Oxide

[20790986001156]

Ethylene Oxide

[20790986001156]

Ethylene Oxide

[20790986001156]

Ethylene Oxide

[20790986001156]

Ethylene Oxide

[20790986001156]

Ethylene Oxide

[20790986001156]

Ethylene Oxide

[20790986001156]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-07-26

On-Brand Devices [MONO-DOX]

• 20790986001279: M380
• 20790986001262: M468
• 20790986001255: M341
• 20790986001248: M195
• 20790986001231: M970
• 20790986001224: M969
• 20790986001217: M968
• 20790986001200: M0112
• 20790986001194: M467
• 20790986001187: M466
• 20790986001163: M451
• 20790986001156: M398
• 20790986001149: M397
• 20790986001132: M340
• 20790986001125: M339
• 20790986001118: M338
• 20790986001101: M334
• 20790986001095: M333
• 20790986001088: M332
• 20790986001071: M317
• 20790986001057: M315
• 20790986001040: M311
• 20790986001033: M310
• 20790986001026: M305
• 20790986001019: M304
• 10790986001005: M184