Parkell® SD110-013

GUDID 10810000526663

Cylinder Flat-End Long Medium Grit FG Diamond ISO# 110-013 (Pkg. of 10 pcs.)

PARKELL, INC.

Diamond dental bur, single-use

• Primary Device ID: 10810000526663
• NIH Device Record Key: 97498c9a-f4e5-4cf2-b15c-128468535c24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parkell®
• Version Model Number: SD110-013
• Catalog Number: SD110-013
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 10
• DM Exempt: true
• Pre-market Exempt: true
• 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: 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
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the material in a cool, dry place. For longest shelf life, refrigerate without freezing.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000526666 [Unit of Use]
GS1	10810000526663 [Primary]

FDA Product Code

• DZP: Instrument, Diamond, Dental

Sterilization

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

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

[10810000526663]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-23
• Device Publish Date: 2019-03-29

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• 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
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• 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
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• 00810000527540: Dry Field Mouth Props (Set of 3 Assorted Props)
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• 10810000522634: Black O-Rings for 25k Scaler Insert (Pkg. of 12 pcs.)
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