DemeLENE

GUDID 30652927317412

Synthetic, Monofilament , Nonabsorbable Suture

DEMETECH CORPORATION

Polyolefin suture, monofilament

• Primary Device ID: 30652927317412
• NIH Device Record Key: f26713b4-68c1-47a3-8ff8-6adeb5d75818
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DemeLENE
• Version Model Number: PM79800,65F0P
• 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
• 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
• 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	10652927317418 [Primary]
GS1	30652927317412 [Package]; Contains: 10652927317418; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043330

FDA Product Code

• GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

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: 2021-04-21
• Device Publish Date: 2021-04-13

On-Brand Devices [DemeLENE]

• 30652927256216: Synthetic (Polypropylene), Non Absorbable Suture
• 30652927224697: Synthetic (polypropylene), Non Absorbable Suture
• 30652927214797: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927202848: Synthetic (Polypropylene), Absorbable Suture
• 30652927201339: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927201094: Synthetic, Monofilament , Nonabsorbable Suture
• 10652927200871: Synthetic, Monofilament , Nonabsorbable Suture
• 10652927200864: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927198134: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927197496: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927196444: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927196437: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927196246: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927196239: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927195386: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927195379: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927193566: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927193474: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927186643: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927181419: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927181396: Synthetic, Monofilament , Nonabsorbable Suture
• 30652927668170: Synthetic (polypropylene), Non Absorbable Suture
• 30652927432849: Synthetic (polypropylene), Non Absorbable Suture
• 30652927432832: Synthetic (polypropylene), Non Absorbable Suture
• 30652927431712: Synthetic (polypropylene), Non Absorbable Suture
• 30652927428217: Synthetic (polypropylene), Non Absorbable Suture
• 30652927427302: Synthetic (polypropylene), Non Absorbable Suture
• 30652927414586: Synthetic (polypropylene), Non Absorbable Suture
• 30652927412469: Synthetic (polypropylene), Non Absorbable Suture
• 30652927397452: Synthetic (polypropylene), Non Absorbable Suture
• 30652927396042: Synthetic (polypropylene), Non Absorbable Suture
• 30652927395656: Synthetic (polypropylene), Non Absorbable Suture
• 30652927394451: Synthetic (polypropylene), Non Absorbable Suture
• 30652927393744: Synthetic (polypropylene), Non Absorbable Suture
• 30652927393416: Synthetic (polypropylene), Non Absorbable Suture
• 30652927379311: Synthetic (polypropylene), Non Absorbable Suture
• 30652927367943: Synthetic (polypropylene), Non Absorbable Suture
• 30652927357401: Synthetic (polypropylene), Non Absorbable Suture
• 30652927337106: Synthetic (polypropylene), Non Absorbable Suture
• 30652927325394: Synthetic (polypropylene), Non Absorbable Suture
• 30652927325370: Synthetic (polypropylene), Non Absorbable Suture
• 30652927325301: Synthetic (polypropylene), Non Absorbable Suture
• 30652927324250: Synthetic (polypropylene), Non Absorbable Suture
• 30652927322287: Synthetic (polypropylene), Non Absorbable Suture
• 30652927322133: Synthetic (polypropylene), Non Absorbable Suture
• 30652927320535: Synthetic (polypropylene), Non Absorbable Suture
• 30652927320023: Synthetic (polypropylene), Non Absorbable Suture
• 30652927320016: Synthetic (polypropylene), Non Absorbable Suture
• 30652927319119: Synthetic (polypropylene), Non Absorbable Suture
• 30652927318921: Synthetic (polypropylene), Non Absorbable Suture