Smith & Nephew

GUDID B504ASC4251010

Provision

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed

• Primary Device ID: B504ASC4251010
• NIH Device Record Key: 0ce6068d-c756-44f7-af4c-5e28882f438f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smith & Nephew
• Version Model Number: ASC4251-01
• 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	B504ASC4251010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173741

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: 2
• Public Version Date: 2020-03-09
• Device Publish Date: 2019-03-19

On-Brand Devices [Smith & Nephew]

• B504EICA9820010: EICA9820-01
• B504EICA8898010: EICA8898-01
• B504EICA8875010: EICA8875-01
• B504EICA7070010: EICA7070-01
• B504EICA5874010: EICA5874-01
• B504EICA4855010: EICA4855-01
• B504EICA4845010: EICA4845-01
• B504EICA4835010: EICA4835-01
• B504CBEICA9820010: EICA9820-01
• B504CBEICA8898010: EICA8898-01
• B504CBEICA8875010: EICA8875-01
• B504CBEICA7070010: EICA7070-01
• B504CBEICA5874010: EICA5874-01
• B504CBEICA4855010: EICA4855-01
• B504CBEICA4845010: EICA4845-01
• B504CBEICA4835010: EICA4835-01
• B504ASC4830010: ASC4830-01
• B504ASC4730010: ASC4730-01
• B504ASC4251010: ASC4251-01
• B504ASC1336010: ASC1336-01
• B504AS722035210: 72203521
• B504AS722030130: 72203013
• B504AS722025310: 72202531
• B504AS722025300: 72202530
• B504AS722004140: 72200414
• B504AS722000950: 72200095
• B504AS722000810: 72200081
• B504AS72109760: 7210976
• B504AS72107510: 7210751
• B504AS72104990: 7210499
• B504AS72104860: 7210486
• B504AS72093030: 7209303
• B504AS72060130: 7206013
• B504AS72060120: 7206012
• B504AS72060110: 7206011
• B504AS72060100: 7206010
• B504AS72054590: 7205459
• B504AS72053450: 7205345
• B504AS72053430: 7205343
• B504AS72053410: 7205341
• B504AS72053200: 7205320
• B504AS72053190: 7205319
• B504AS72053180: 7205318
• B504AS72053170: 7205317
• B504AS72053160: 7205316
• B504AS72053150: 7205315
• B504AS72053140: 7205314
• B504AS72053130: 7205313
• B504AS72053120: 7205312
• B504AS72053110: 7205311