Ambler Surgical PR7425

GUDID 00190660000998

Bipolar pencil, 20/23 gauge, non-stick, sharp tapered tip, reusable

AMBLER SURGICAL CORP.

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00190660000998
• NIH Device Record Key: f0b37e7b-df3c-46c7-ae68-24c150e2b3a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambler Surgical
• Version Model Number: PR7425
• Catalog Number: PR7425
• Company DUNS: 015272206
• Company Name: AMBLER SURGICAL CORP.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)407-0006
• Email: sales@amblersurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190660000998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864402

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

[00190660000998]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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• 00190660194055: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved up 45º,
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