Baolai

GUDID 16970557950442

Nanning Baolai medical instrument Co.,Ltd

Ultrasonic dental scaling/debridement system

• Primary Device ID: 16970557950442
• NIH Device Record Key: a52bfb04-a28c-4b1d-ab36-517102423b4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baolai
• Version Model Number: BCL-A
• Company DUNS: 544921355
• Company Name: Nanning Baolai medical instrument Co.,Ltd
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	16970557950442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140233

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

[16970557950442]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-14
• Device Publish Date: 2021-06-04

On-Brand Devices [Baolai]

• 16970557950244: P9-2
• 16970557950237: CD3
• 16970557950220: CD2
• 16970557950213: CD1
• 16970557950206: C5L
• 16970557950190: BD2
• 16970557950183: B5L
• 16970557950176: P9L
• 16970557950169: P9
• 16970557950152: C7L
• 16970557950145: C7
• 16970557950138: C6
• 16970557950121: C5S
• 16970557950114: C5
• 16970557950107: P7L
• 16970557950091: P7
• 16970557950084: P6
• 16970557950077: B6S
• 16970557950060: B6
• 16970557950053: P5L
• 16970557950046: P5
• 16970557950039: P4
• 16970557950022: B5S
• 16970557950015: B5
• 16970557950459: MPT1
• 16970557950442: BCL-A
• 16970557950435: CL-A
• 16970557950428: ESS1
• 16970557950411: ME-A
• 16970557950404: FS-B
• 16970557950398: FS-A
• 06970557950469: K10