DemeSTEEL

GUDID 30652927248754

Stainless Steel Surgical Non Absorbable Suture

DEMETECH TRADING CORPORATION

Metallic suture, multifilament

• Primary Device ID: 30652927248754
• NIH Device Record Key: eb99e54c-5456-41b0-88fd-362c3e3ae3c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DemeSTEEL
• Version Model Number: SW110026B0P
• Company DUNS: 039436691
• Company Name: DEMETECH TRADING 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10652927248750 [Primary]
GS1	30652927248754 [Package]; Contains: 10652927248750; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141007

FDA Product Code

• GAQ: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

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: 2019-05-07
• Device Publish Date: 2017-08-31

Devices Manufactured by DEMETECH TRADING CORPORATION

• 30652927197373 - DemeGUT: 2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
• 30652927197441 - DemeGUT: 2019-06-12 Plain Gut, Sterile, Absorbable Surgical Suture
• 30652927206938 - DemeGUT: 2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
• 30652927213042 - DemeGUT: 2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
• 30652927214940 - DemeGUT: 2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
• 30652927214957 - DemeGUT: 2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
• 30652927222167 - DemeGUT: 2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
• 30652927222174 - DemeGUT: 2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture