Ambler Surgical PR7410

GUDID 00190660000936

Bipolar pencil, 18 gauge, non-stick, straight tip, reusable

AMBLER SURGICAL CORP.

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00190660000936
• NIH Device Record Key: f3e08e24-a563-4de7-a234-dfbca13df7c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambler Surgical
• Version Model Number: PR7410
• Catalog Number: PR7410
• 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	00190660000936 [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

[00190660000936]

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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• 00190660018917: Bilateral oval conformer, made of PMMA plastic, regular, without holes, packaged individually, n
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• 00190660194185: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved down 45º
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• 00190660194161: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, straight, 1.5mm
• 00190660194154: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved down 45º
• 00190660194147: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved up 45º,
• 00190660194130: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, straight, 1.2mm
• 00190660194123: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved down 45º
• 00190660194116: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved up 45º,
• 00190660194109: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, straight, 0.7mm
• 00190660194093: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved down 45º
• 00190660194086: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, curved up 45º,
• 00190660194079: MicroGlide MIS bipolar forceps, 11 3/4", working length 7 3/4", bayonet shafts, straight, 0.4mm
• 00190660194062: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved down 45º
• 00190660194055: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved up 45º,
• 00190660194048: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, straight, 1.5mm
• 00190660194031: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved down 45º
• 00190660194024: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved up 45º,
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• 00190660193973: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved down 45º
• 00190660193966: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved up 45º,
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• 00190660193928: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, straight, 1.5mm w
• 00190660193911: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved down 45º,
• 00190660193904: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved up 45º, 1
• 00190660193898: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, straight, 1.2mm w
• 00190660193881: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved down 45º,
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• 00190660193867: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, straight, 0.7mm w
• 00190660193850: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved down 45º,
• 00190660193843: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, curved up 45º, 0
• 00190660193836: MicroGlide MIS bipolar forceps, 9 1/4", working length 5 1/4", bayonet shafts, straight, 0.4mm w