DePuy Mitek

GUDID B504AE2272040

Provision

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed

• Primary Device ID: B504AE2272040
• NIH Device Record Key: 28090c73-934e-4809-a0a1-911699edab37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DePuy Mitek
• Version Model Number: 227204
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B504AE2272040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173740

FDA Product Code

• NUJ: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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: 2020-03-09
• Device Publish Date: 2018-04-04

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