N/A 29-BIPOLAR-S-10

GUDID 00846468049270

Bipolar Forceps, Straight, 9.7", 1.0mm

Pioneer Surgical Technology, Inc.

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00846468049270
• NIH Device Record Key: 275ed750-59ee-40e4-b837-084f49bae905
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 29-BIPOLAR-S-10
• Catalog Number: 29-BIPOLAR-S-10
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468049270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123478

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

Moist Heat or Steam Sterilization

[00846468049270]

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: 2017-01-12

On-Brand Devices [N/A]

• 00846468060787: Bipolar Forceps, Straight, 9.7", 0.4mm
• 00846468060527: Bipolar Forceps, Bent, 9.7", Small
• 00846468060510: Bipolar Forceps, Straight, 9.7", Small
• 00846468060466: Bipolar Forceps, Bent, 9.7", 1.5mm Tip
• 00846468060435: Bipolar Forceps, Bent, 9.7", 1.0mm Tip
• 00846468060404: Bipolar Forceps, Bent, 9.7", 0.4mm Tip
• 00846468057572: AUXILIARY CASE
• 00846468050542: Bone Graft Delivery System
• 00846468049386: Bipolar Forceps, Straight, 9.7", 1.5mm
• 00846468049287: Bipolar Forceps, Straight, 9.7", Large
• 00846468049270: Bipolar Forceps, Straight, 9.7", 1.0mm
• 00846468041052: AWL
• 00846468041045: HEX DRIVER, 3.5mm