DemeDIOX

GUDID 30652927201797

Absorbable Polydioxanone Surgical Suture

DEMETECH CORPORATION

Polyester suture, bioabsorbable, monofilament

• Primary Device ID: 30652927201797
• NIH Device Record Key: d6b8e774-81fb-4b8a-95d5-3c4edb5912f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DemeDIOX
• Version Model Number: PX580148BI0P
• Company DUNS: 039436691
• Company Name: DEMETECH 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us
• Phone: 3058241048
• Email: info@demetech.us

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10652927201793 [Primary]
GS1	30652927201797 [Package]; Contains: 10652927201793; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082097

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

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: 2019-06-25
• Device Publish Date: 2019-06-17

On-Brand Devices [DemeDIOX]

• 30652927413688: Absorbable Polydioxanone Surgical Suture
• 30652927257602: Absorbable Polydioxanone Surgical Suture
• 30652927250566: Absorbable Polydioxanone Surgical Suture
• 30652927250559: Absorbable Polydioxanone Surgical Suture
• 30652927241687: Absorbable Polydioxanone Surgical Suture
• 30652927241557: Absorbable Polydioxanone Surgical Suture
• 30652927231305: Absorbable Polydioxanone Surgical Suture
• 30652927222280: Absorbable Polydioxanone Surgical Suture
• 30652927215800: Absorbable Polydioxanone Surgical Suture
• 30652927214643: Absorbable Polydioxanone Surgical Suture
• 30652927214063: Absorbable Polydioxanone Surgical Suture
• 30652927208826: Absorbable Polydioxanone Surgical Suture
• 30652927201858: Absorbable Polydioxanone Surgical Suture
• 30652927199216: Synthetic (Polydioxanone), Absorbabble Suture
• 30652927198073: Absorbable Polydioxanone Surgical Suture
• 30652927187695: Absorbable Polydioxanone Surgical Suture
• 30652927187688: Absorbable Polydioxanone Surgical Suture
• 30652927187671: Absorbable Polydioxanone Surgical Suture
• 30652927187664: Absorbable Polydioxanone Surgical Suture
• 30652927185905: Absorbable Polydioxanone Surgical Suture
• 30652927185899: Absorbable Polydioxanone Surgical Suture
• 30652927185882: Absorbable Polydioxanone Surgical Suture
• 30652927185875: Absorbable Polydioxanone Surgical Suture
• 30652927668989: Absorbable Polydioxanone Surgical Suture
• 30652927668262: Absorbable Polydioxanone Surgical Suture
• 30652927668255: Absorbable Polydioxanone Surgical Suture
• 30652927668248: Absorbable Polydioxanone Surgical Suture
• 30652927668231: Absorbable Polydioxanone Surgical Suture
• 30652927668224: Absorbable Polydioxanone Surgical Suture
• 30652927667760: Absorbable Polydioxanone Surgical Suture
• 30652927667746: Absorbable Polydioxanone Surgical Suture
• 30652927667739: Absorbable Polydioxanone Surgical Suture
• 30652927667722: Absorbable Polydioxanone Surgical Suture
• 30652927667685: Absorbable Polydioxanone Surgical Suture
• 30652927667616: Absorbable Polydioxanone Surgical Suture
• 30652927667593: Absorbable Polydioxanone Surgical Suture
• 30652927667456: Absorbable Polydioxanone Surgical Suture
• 30652927432900: Absorbable Polydioxanone Surgical Suture
• 30652927432856: Absorbable Polydioxanone Surgical Suture
• 30652927432825: Absorbable Polydioxanone Surgical Suture
• 30652927432818: Absorbable Polydioxanone Surgical Suture
• 30652927432320: Absorbable Polydioxanone Surgical Suture
• 30652927432313: Absorbable Polydioxanone Surgical Suture
• 30652927432306: Absorbable Polydioxanone Surgical Suture
• 30652927432290: Absorbable Polydioxanone Surgical Suture
• 30652927431033: Absorbable Polydioxanone Surgical Suture
• 30652927430913: Absorbable Polydioxanone Surgical Suture
• 30652927430906: Absorbable Polydioxanone Surgical Suture
• 30652927430890: Absorbable Polydioxanone Surgical Suture
• 30652927430883: Absorbable Polydioxanone Surgical Suture