NSK Sterile Burs/Drills

GUDID 04589551353026

NAKANISHI INC.

Orthopaedic bur, single-use

• Primary Device ID: 04589551353026
• NIH Device Record Key: 73f5ffa4-6dcd-474c-bb9c-744e5e411fd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NSK Sterile Burs/Drills
• Version Model Number: PDS-1RD170-40
• Company DUNS: 690710546
• Company Name: NAKANISHI 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04589551353026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202120

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

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: 2022-10-12
• Device Publish Date: 2022-10-04

On-Brand Devices [NSK Sterile Burs/Drills]

• 04589551352807: PDS-2BCDL-50E
• 04589551352791: PDS-2BCDL-30E
• 04589551352784: PDS-2BCDL-50
• 04589551352777: PDS-2BCDL-30
• 04589551351596: PDS-3NCBL-30
• 04589551351589: PDS-3NCBL-22
• 04589551351572: PDS-3NCBL-18
• 04589551351565: PDS-3NCBM-30
• 04589551351558: PDS-3NCBM-22
• 04589551351541: PDS-3NCBM-18
• 04589551351534: PDS-3NCBS-30
• 04589551351527: PDS-3NCBS-22
• 04589551351510: PDS-3NCBS-18
• 04589551351503: PDS-2NCBL-30
• 04589551351497: PDS-2NCBL-22
• 04589551351480: PDS-2NCBL-18
• 04589551351473: PDS-2NCBM-30
• 04589551351466: PDS-2NCBM-22
• 04589551351459: PDS-2NCBM-18
• 04589551351442: PDS-2NCBS-30
• 04589551351435: PDS-2NCBS-22
• 04589551351428: PDS-2NCBS-18
• 04589551351411: PDS-2NCBES-30
• 04589551351404: PDS-2NCBES-22
• 04589551351398: PDS-2NCBES-18
• 04589551351381: PDS-2NCBMS-30
• 04589551351374: PDS-2NCBMS-22
• 04589551351367: PDS-2NCBMS-18
• 04589551350407: PDS-2CDES-15E
• 04589551350391: PDS-2CDES-10E
• 04589551350384: PDS-1MHC175-30
• 04589551350377: PDS-1MHC175-25
• 04589551350360: PDS-1MHC155-30
• 04589551350353: PDS-1MHC155-25
• 04589551350346: PDS-3NL-22
• 04589551350339: PDS-3NM-22
• 04589551350322: PDS-3NS-22
• 04589551350315: PDS-2NL-22
• 04589551350308: PDS-2NM-22
• 04589551350292: PDS-2NS-22
• 04589551350285: PDS-2NES-22
• 04589551350278: PDS-2NMS-22
• 04589551350254: PDS-1C175-40
• 04589551350247: PDS-1C175-30
• 04589551350230: PDS-1C175-20
• 04589551350223: PDS-1C155-40
• 04589551350216: PDS-1C155-30
• 04589551350209: PDS-1C155-20
• 04589551350193: PDS-2AS-60
• 04589551350186: PDS-2AES-60