DePuy Mitek

GUDID B504AS2833190

Provision

Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed

• Primary Device ID: B504AS2833190
• NIH Device Record Key: b98a96a7-66c5-45a5-808e-3e1ee64849c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DePuy Mitek
• Version Model Number: 283319
• Company DUNS: 016889401
• Company Name: Provision
• 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: true
• 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: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B504AS2833190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172092

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-11
• Device Publish Date: 2021-03-03

On-Brand Devices [DePuy Mitek]

• B504TC2141220: 214122
• B504TC2141200: 214120
• B504TC2141180: 214118
• B504TC2141160: 214116
• B504TC2141150: 214115
• B504TC2141140: 214114
• B504TC2141100: 214110
• B504TC2141080: 214108
• B504TC2141070: 214107
• B504TC2141060: 214106
• B504TC2141040: 214104
• B504SR2141410: 214141
• B504OMFDB200: FDB 20
• B504OM2193770: 219377
• B504OM211036: 211036
• B504AE2285040: 228504
• B504AE2283700: 228370
• B504AE2283050: 228305
• B504AE2283000: 228300
• B504AE2282030: 228203
• B504AE2281470: 228147
• B504AE2281460: 228146
• B504AE2275040: 227504
• B504AE2273550: 227355
• B504AE2273120: 227312
• B504AE2273050: 227305
• B504AE2273040: 227304
• B504AE2273020: 227302
• B504AE2273010: 227301
• B504AE2272130: 227213
• B504AE2272110: 227211
• B504AE2272040: 227204
• B504AE2272030: 227203
• B504AE2272020: 227202
• B504AE2253700: 225370
• B504AE2253610: 225361
• B504AE2253600: 225360
• B504AE2253140: 225314
• B504AE2253120: 225312
• B504AE2253050: 225305
• B504AE2253040: 225304
• B504AE2253030: 225303
• B504AE2253020: 225302
• B504AE2253010: 225301
• B504AE2252130: 225213
• B504AE2252110: 225211
• B504AE2252030: 225203
• B504AE2252020: 225202
• B504AE2252010: 225201
• B5042285040: 228504