FDA.report

Sterile Cutting Tool

Primary DI
04589551366613
Brand
Sterile Cutting Tool
Company
NAKANISHI INC.
Model
UBS-RD50C2-07
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Product Code Classifications

CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Premarket Submissions

SubmissionSupplement
K252662000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K252662000UniBurNakanishi, Inc.2025-09-19HBE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04589551366613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04589551366613045895513666134589551366613

GMDN Terms

TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads.

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04589551366583Sterile Cutting ToolUBS-RD70C2-082026-05-22
04589551366590Sterile Cutting ToolUBS-RD70C2-072026-05-22
04589551366606Sterile Cutting ToolUBS-RD50C2-082026-05-22
04589551388929VA170LUX-SCVA170LUX-SC2026-02-13
04589551388936VA170-SCVA170-SC2026-02-13
04589551388981Potentiometer SetPotentiometer Set2026-02-13
04589551389452VariosG162026-02-13
04589551383900VariosScaling G16 Pack2026-02-13
04589551389476Perio Kit APerio Kit A2026-02-13
04589551389483VA170VA1702026-02-13
04560264577763VA2-LUX-HP TiVA2-LUX-HP Ti2026-02-13
04589551387168Tip Cover LTip Cover L2026-01-21
04589551387151Tip Cover STip Cover S2026-01-21
04589551382828E TIP WRENCHE TIP WRENCH2026-01-21
04589551387144VariosCR-12026-01-21
04560264579958CLA-10CLA-102026-01-21
045895513889743 Mode Select Switch3 Mode Select Switch2026-01-21
04589551383863VariosG12022-12-13
04589551383870VariosG42022-12-13
04589551383887VariosG62022-12-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04589551366583Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366590Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366606Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
B775635CK0PHASORPHASOR HEALTH LLCHBE2026-01-19
B7752IN125LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN126K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN126LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN145LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1246K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1246LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1256LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7754IN1K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7754IN1LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7755IN1LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B775GREDBA0PHASORPHASOR HEALTH LLCHBE2025-11-24
B775GREDRI0PHASORPHASOR HEALTH LLCHBE2025-11-24
00763000679682POWEREASE™ InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HBE2025-07-28
00763000683511POWEREASE™ InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HBE2025-07-27
00763000722388MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-25
00763000722319ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-25
00763000722418MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-21
00763000988784Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-17
00763000892722Midas Rex ClearviewMEDTRONIC XOMED, INC.HBE2025-06-23
06429811532069Surgify Halo | 4.0 mm | ShortSurgify Medical OyHBE2025-06-18
06429811532076Surgify Halo | 4.0 mm | ExtendableSurgify Medical OyHBE2025-06-18
06429811532083Surgify Halo | 4.0 mm | LongSurgify Medical OyHBE2025-06-18
15059358034986ZethonZETHON LIMITEDHBE2025-05-14
05059358036457ZethonZETHON LIMITEDHBE2025-05-14
15059358036478ZethonZETHON LIMITEDHBE2025-05-14
15059358036492ZethonZETHON LIMITEDHBE2025-05-14