Drtm6 8-0 Vio Br Pga 5"/13cm GA-401

GUDID 10848782015372

Drtm6 8-0 Vio Br Pga 5"/13cm

Surgical Specialties México, S. de R.L. de C.V.

Polyglycolic acid suture

• Primary Device ID: 10848782015372
• NIH Device Record Key: f7081ce7-25f8-4357-91bc-7b699fad15c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drtm6 8-0 Vio Br Pga 5"/13cm
• Version Model Number: GA-401N
• Catalog Number: GA-401
• Company DUNS: 812762226
• Company Name: Surgical Specialties México, S. de R.L. de C.V.
• Device Count: 1
• DM Exempt: true
• 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: +1(877)991-1110
• Email: service@surgicalspecialties.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848782015375 [Primary]
GS1	10848782015372 [Package]; Contains: 00848782015375; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141625

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-21

Devices Manufactured by Surgical Specialties México, S. de R.L. de C.V.

• 20705031227634 - Stratafix Spiral: 2023-12-25 PS-2 2-0 MONODERM 60CM
• 20705031227986 - Stratafix Spiral: 2023-12-25 PS-2 3-0 MONODERM 30CM
• 20705031227993 - Stratafix Spiral: 2023-12-25 CT-1 0 MONODERM 45CM
• 20705031228006 - Stratafix Spiral: 2023-12-25 PS-2 3-0 MONODERM 60CM
• 20705031228013 - Stratafix Spiral: 2023-12-25 PS-2 2-0 MONODERM 30CM
• 20705031228020 - Stratafix Spiral: 2023-12-25 CT-1 1 MONODERM 45CM
• 20705031228037 - Stratafix Spiral: 2023-12-25 SH 0 MONODERM 20CM
• 20705031228044 - Stratafix Spiral: 2023-12-25 PS-1 2-0 MONODERM 30CM