5-0 Undyd Monoderm 14x14

GUDID 10848782022042

5-0 Undyd Monoderm 14x14

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

Poliglecaprone suture

• Primary Device ID: 10848782022042
• NIH Device Record Key: 4351ee3b-4eeb-4168-8026-e43ea0cd6604
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5-0 Undyd Monoderm 14x14
• Version Model Number: YA-2002Q
• 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	00848782022045 [Primary]
GS1	10848782022042 [Package]; Contains: 00848782022045; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141558

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: 2015-10-22

On-Brand Devices [5-0 Undyd Monoderm 14x14]

• 10848782022059: 5-0 Undyd Monoderm 14x14
• 10848782022042: 5-0 Undyd Monoderm 14x14