Next Gen Driver

GUDID M791NGD10000

BIOACCESS INC

Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use

• Primary Device ID: M791NGD10000
• NIH Device Record Key: 7930e25a-604e-4b21-8d8f-fbb83610fc91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Next Gen Driver
• Version Model Number: NGD1000
• Company DUNS: 942203001
• Company Name: BIOACCESS INC
• Device Count: 1
• DM Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
HIBCC	M791NGD10000 [Primary]

FDA Product Code

• GFF: Bur, Surgical, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-12
• Device Publish Date: 2022-08-04

On-Brand Devices [Next Gen Driver]

• M791NGD1005A0: NGD1005A
• M791NGD10000: NGD1000