NSK Sterile Burs/Drills

GUDID 04589551353026

NAKANISHI INC.

Orthopaedic bur, single-use
Primary Device ID04589551353026
NIH Device Record Key73f5ffa4-6dcd-474c-bb9c-744e5e411fd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNSK Sterile Burs/Drills
Version Model NumberPDS-1RD170-40
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104589551353026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-12
Device Publish Date2022-10-04

On-Brand Devices [NSK Sterile Burs/Drills]

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

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