NSK Sterile Burs/Drills

GUDID 04589551353347

NAKANISHI INC.

Orthopaedic bur, single-use

Primary Device ID	04589551353347
NIH Device Record Key	a3cdb491-1c3e-4988-ade5-0c3706ec56d5
Commercial Distribution Status	In Commercial Distribution
Brand Name	NSK Sterile Burs/Drills
Version Model Number	PDS-1RTD130-45
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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04589551353347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K202120

FDA Product Code

HBE	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

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	2022-10-14
Device Publish Date	2022-10-06

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