287428

GUDID 20886705000477

Ultra-Aggressive Plus Shaver Blades 5.0mm

DEPUY MITEK, LLC

Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use 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

• 20886705002174 - PANACRYL: 2024-06-03 Rotator Cuff EasyAnchor with PANACRYL Size 2 (5 metric) PANACRYL braided absorbable suture, 36 Inches (91 cm), double-armed with
• 10886705008292 - FASTIN PANACRYL: 2024-06-03 FASTIN RC Anchor with PANACRYL Titanium Anchor with two Number 2 PANACRYL Poly (L-Lactide/Glycolide) Braided Absorbable Sutures,
• 10886705009374 - VAPR: 2024-06-03 VAPR LD Suction Electrode 4 mm x 160 mm
• 10886705009381 - VAPR: 2024-06-03 VAPR LP Suction Electrode 4 mm x 160 mm
• 10886705000913 - NA: 2024-05-30 Rotator Cuff Anchor Threader Tab
• 10886705001064 - LUPINE ORTHOCORD: 2024-05-30 LUPINE Loop Plus Anchor w/ORTHOCORD Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD Braided Composite Sut
• 10886705001071 - LUPINE ORTHOCORD: 2024-05-30 LUPINE Loop PLUS Dual Suture (DS) Anchor w/ORTHOCORD PLA Absorbable Anchor, with two size 2 (5 metric) ORTHOCORD braided composi
• 10886705002412 - QUICKANCHOR PANACRYL: 2024-05-30 MINILOK QUICKANCHOR Plus (Number 2/0) Suture Poly (L-lactide) absorbable anchor, size 2/0 PANACRYL braided absorbable suture (3