Parkell® S397-P04

GUDID M595S397P040

P4 Proximal Hemostasis Electrosurge Electrode

PARKELL, INC.

Open-surgery electrosurgical electrode, monopolar, reusable

• Primary Device ID: M595S397P040
• NIH Device Record Key: b6f77e5c-32b3-4e59-be50-10caad25a7ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parkell®
• Version Model Number: P-04
• Catalog Number: S397-P04
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000526727 [Primary]
HIBCC	M595S397P040 [Previous]

FDA Product Code

• EKZ: Unit, Electrosurgical, And Accessories, Dental

Sterilization

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

[M595S397P040]

Moist Heat or Steam Sterilization

[M595S397P040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-14

On-Brand Devices [Parkell®]

• 00810000529605: Parkell® LC Fill in 2.5ml Syringe
• 00810000529599: Parkell® LC Base in 2.5ml Syringe
• M595S397T160: T-16 Electrosurge Electrode
• M595S397T080: T-8 Electrosurge Electrode
• M595S397T050: T-5 Electrosurge Electrode
• M595S397T020: T-2 Electrosurge Electrode
• M595S397P040: P4 Proximal Hemostasis Electrosurge Electrode
• M595S397C030: C-3 Electrosurge Electrode
• 00810000525348: Parkell® Universal Adhesive Kit
• 00810000522897: Universal 30k Internal Water Scaler Insert
• 00810000522880: Universal 25k Internal Water Scaler Insert
• 00810000522859: Pink Soft-Grip 30k Universal Ultrasonic Scaler Insert
• 00810000522842: Soft-Grip Universal 30k Internal Water Ultrasonic Scaler Tip
• 00810000522828: Pink Soft-Grip 30k Right Curved Perio Ultrasonic Scaler Insert
• 00810000522811: Soft-Grip Right Curved Perio Tip 30k Internal Water Ultrasonic Scaler Insert
• 00810000522804: Pink Soft-Grip Perio 30k Ultrasonic Scaler Tip (Internal Water)
• 00810000522798: Soft-Grip Perio 30k Internal Water Ultrasonic Scaler Tip
• 00810000522781: Pink Soft-Grip 30k Left Curved Perio Ultrasonic Scaler Insert
• 00810000522767: Soft-Grip Left Curved Perio Tip 30k Internal Water Ultrasonic Scaler Tip
• 00810000522699: 25k Right-Curved Perio Scaler Insert
• 00810000522682: 30k Left-Curved Perio Scaler Insert
• 00810000522675: 25k Left-Curved Perio Scaler Insert
• 00810000522668: Perio 30k Internal Water Scaler Insert
• 00810000522651: Perio 25k Internal Water Scaler Insert
• 00810000522514: Beavertail 30k Internal Water Scaler Insert
• 00810000522507: Beavertail 25k Internal Water Scaler Insert
• 00810000521814: Dual-Stage Foot Switch for D560 (110v & 230v) & D690 (100v, 110v & 230v)
• 00810000520640: Parkell® 110 Volt Auto/Manual Tune Ultrasonic Tooth Scaler with Autoclavable Handpiece
• 00810000520619: Type-G Cordset for Power Transformer
• 00810000520589: Parkell® Autoclavable Handpiece Sheath without logo for Turbo 25/30, TurboSENSOR® D560, D590 &
• 00810000520572: Parkell® Autoclavable Handpiece Sheath for Turbo 25/30, TurboSENSOR® D560, D590 & D595
• 00810000520183: Charging Stand for Parkell® D553 Curing Light
• 00810000520176: Replacement Battery for Parkell® D553 Curing Light
• 00810000520169: Wall Mount Power Transformer for Parkell® D553 Curing Light
• 00810000520152: Parkell® Curing Light
• 00810000520053: Parkell® Aluminum Oxide (50 micron) 5 Lbs.
• 10810000526663: Cylinder Flat-End Long Medium Grit FG Diamond ISO# 110-013 (Pkg. of 10 pcs.)
• 10810000526656: Barrel Medium Grit FG Diamond ISO# 038-035 (Pkg. of 10 pcs.)
• 10810000526649: Hourglass Medium Grit FG Diamond ISO# 019-014 (Pkg. of 10 pc
• 10810000526632: Acorn Medium Grit FG Diamond ISO# 031-030 (Pkg. of 10 pcs.)
• 10810000527530: Large Posterior Dry Field Mouth Props (Set of 3 Props)
• 00810000527540: Dry Field Mouth Props (Set of 3 Assorted Props)
• 10810000527035: POLYETHYLENE PLASTIC PIPETS/DROPPERS (Pkg. of 25 pcs.)
• 10810000526557: Taper Flat-End Coarse Grit FG Diamond ISO# 6874-017 (Pkg. of 10 pcs.)
• 10810000522641: Green O-Ring for 30k Scaler Insert (Pkg. of 12 pcs.)
• 10810000522634: Black O-Rings for 25k Scaler Insert (Pkg. of 12 pcs.)
• 00810000520855: 3-Piece Outlet Adaptor Set for Parkell Curing Light Transformer
• 10810000526540: Cylinder Flat-End Coarse Grit FG Diamond ISO# 6835-017 (Pkg. of 10 pcs.)
• 10810000526625: Long Round End Parallel Sided Medium Grit FG Diamond (Pkg. of 10 pcs.)
• 10810000526618: Wheel Coarse Grit FG Diamond ISO# 6909-048 (Pkg. of 10 pcs.)