287428

GUDID 20886705000477

Ultra-Aggressive Plus Shaver Blades 5.0mm

DEPUY MITEK, LLC

Arthroscopic shaver system blade, single-use

• Primary Device ID: 20886705000477
• NIH Device Record Key: df791a2c-942c-4a53-8747-15016ca7f674
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 287428
• Catalog Number: 287428
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705000470 [Primary]
GS1	20886705000477 [Package]; Contains: 10886705000470; Package: PACKAGE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954465

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-07-04
• Device Publish Date: 2017-03-17

Devices Manufactured by DEPUY MITEK, LLC

• 20886705000903 - NA: 2025-09-29 SuperAnchor Threader Tab
• 10886705000951 - NA: 2025-09-29 SuperAnchor Threader Tab
• 10886705001088 - LUPINE ETHIBOND: 2025-09-29 LUPINE Loop PLUS Anchor w/ETHIBOND PLA Absorbable Anchor, size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (
• 10886705001958 - QUICKANCHOR PANACRYL: 2025-09-29 Rotator Cuff QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), with CP-2 needles, with dis
• 10886705001989 - GII QUICKANCHOR PANACRYL: 2025-09-29 GII QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), double armed with CP-2 needles, with
• 10886705001996 - QUICKANCHOR PANACRYL: 2025-09-29 Super QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), double armed with CP-2 needles, wi
• 10886705002047 - ETHIBOND: 2025-09-29 Rotator Cuff EasyAnchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), with disposable inserter
• 20886705002051 - ETHIBOND: 2025-09-29 Rotator Cuff EasyAnchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), with disposable inserter