FDA.reportPublic FDA data

P300-2S120

Primary DI
04589551366361
Brand
P300-2S120
Company
NAKANISHI INC.
Model
P300-2S120
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202120000P300 AttachmentNakanishi, Inc.2021-10-22HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589551366460Direct MarkingGS10
04589551366361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589551366460045895513664604589551366460
04589551366361045895513663614589551366361

GMDN Terms#

Term, Definition table
TermDefinition
Drilling power tool attachment, basicA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690710546
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589551388899VA170LUXS10VA170LUXS102026-10-06
04560264508422VA-SG-SCVA-SG-SC2026-10-05
04560264501911VA750LUX-SCVA750LUX-SC2026-10-01
04560264501935VA750-SCVA750-SC2026-10-01
04560264501942VA-SCVA-SC2026-10-01
04560264501980Water Filter Set (2m)Water Filter Set (2m)2026-10-01
04560264503649VA560LUX-SCVA560LUX-SC2026-10-01
04560264519022VA970-SCVA970-SC2026-10-01
04560264519039VA970LUX-SCVA970LUX-SC2026-10-01
04560264522510VA570-SCVA570-SC2026-10-01
04560264522527VA570LUX-SCVA570LUX-SC2026-10-01
04560264535213Water Filter Set (4m)Water Filter Set (4m)2026-10-01
04589551386765FC-15FC-152023-06-05
04560264522336Torque CalibratorTorque Calibrator2020-11-20
04560264566453NLZNLZ CDE2020-07-07
04560264565845TI-MAX X CONTRA/HPX95L2020-06-12
04560264565869TI-MAX X CONTRA/HPX25L2020-06-12
04560264565876TI-MAX X CONTRA/HPX20L2020-06-12
04560264565883TI-MAX X CONTRA/HPX15L2020-06-12
04560264565906TI-MAX X CONTRA/HPX952020-06-12

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