NSK Sterile Blades

GUDID 04560264516311

NAKANISHI INC.

Sagittal surgical saw blade, single-use

• Primary Device ID: 04560264516311
• NIH Device Record Key: 7977e330-bece-4aee-b6f6-079fc2042f1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NSK Sterile Blades
• Version Model Number: PDS-SO-422
• 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.
• 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	04560264516311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132264

FDA Product Code

• HBC: MOTOR, DRILL, ELECTRIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [NSK Sterile Blades]

• 04560264548534: PDS-RE-4028E
• 04560264548527: PDS-RE-4023E
• 04560264516625: PDS-SO-653
• 04560264516502: PDS-RE-4223
• 04560264516496: PDS-RE-4217
• 04560264516489: PDS-RE-4114
• 04560264516472: PDS-RE-4028
• 04560264516465: PDS-RE-4023
• 04560264516458: PDS-RE-6127
• 04560264516441: PDS-RE-4127
• 04560264516434: PDS-OSC-432
• 04560264516427: PDS-OSC-422
• 04560264516410: PDS-SO-642
• 04560264516403: PDS-SO-632
• 04560264516380: PDS-SO-453
• 04560264516373: PDS-SO-452
• 04560264516366: PDS-SO-442
• 04560264516359: PDS-SO-441
• 04560264516342: PDS-SO-433
• 04560264516335: PDS-SO-432
• 04560264516328: PDS-SO-431
• 04560264516311: PDS-SO-422
• 04560264516304: PDS-SO-412
• 04560264516298: PDS-SO-411