Primado2

GUDID 04560264561304

NAKANISHI INC.

Multi-purpose surgical power tool system, line-powered

• Primary Device ID: 04560264561304
• NIH Device Record Key: 4f3dbd93-4600-44af-ad74-de87b77a666b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primado2
• Version Model Number: PD-SA-R
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560264561304 [Primary]
GS1	04589551352623 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132264

FDA Product Code

• HBC: MOTOR, DRILL, ELECTRIC

Sterilization

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

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

[04560264561304]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-16

On-Brand Devices [Primado2]

• 04589551350421: P200-CRA
• 04560264561519: P200-3MC
• 04560264561502: PD-CRD-L
• 04560264561496: PD-CRD-M
• 04560264561489: PD-CRD-P
• 04560264561472: P200-CA-4
• 04560264561465: P200-RA330-L
• 04560264561458: PD-RA155
• 04560264561441: PD-RA135
• 04560264561434: P200-RA155
• 04560264561427: P200-RA135
• 04560264561410: P200-1A135
• 04560264561403: PD-RA-H
• 04560264561397: PD-RA-M
• 04560264561380: PD-CA-64
• 04560264561373: PD-2ADM
• 04560264561366: P200-3GAS
• 04560264561359: PD-1A135
• 04560264561342: P200-OSC-S-HS
• 04560264561335: P200-REC-S-HS
• 04560264561328: PD-RA-T
• 04560264561311: P200-RA330
• 04560264561304: PD-SA-R
• 04560264561298: PD-2SM
• 04560264561281: PD-2AL
• 04560264561274: P200-1A175
• 04560264561267: P200-1A155
• 04560264561250: P200-2SL
• 04560264561243: PD-DA-K
• 04560264561236: PD-1A175-10
• 04560264561229: PD-1A155-10
• 04560264561212: PD-RA330-L
• 04560264561205: PD-2AD
• 04560264561199: P200-SAG-S-HS
• 04560264561182: P200-2SMS
• 04560264561175: PD-RA330
• 04560264561168: P200-1A175-C
• 04560264561151: PD-2SS
• 04560264561144: PD-CA-16
• 04560264561137: P200-3GAL
• 04560264561120: P200-HMH-HS
• 04560264561113: P200-BMH-HS
• 04560264561106: PD-2AM
• 04560264561090: PD-2SDM
• 04560264561083: P200-2AMS
• 04560264561076: PD-RA-A
• 04560264561069: P200-2SM
• 04560264561052: PD-DA-J4
• 04560264561045: P200-SAG
• 04560264561038: PD-2AS