FDA.reportPublic FDA data

TruDi Shaver Blade

Primary DI
20705031469256
Brand
TruDi Shaver Blade
Company
ACCLARENT, INC.
Model
TSB3STRZ
Catalog number
TSB3STRZ
Device description
Trudi Shaver Blade 3.0mm - Straight (0°)- 1pk
Published
2022-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
PGWEar, Nose, and Throat Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221037000TruDi Shaver BladeAcclarent, Inc.2022-07-20PGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031469256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503146925620705031469256

GMDN Terms#

Term, Definition table
TermDefinition
Metal/carbide ENT bur, single-useA small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(650)687-5888xx@xx.xx
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
361092450
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031245853TruDi NAV CableTDNC001TDNC0012018-10-31
10705031245877TruDi NAV SuctionTDNS000ZTDNS000Z2019-01-20
10705031245884TruDi NAV SuctionTDNS070ZTDNS070Z2019-01-20
10705031245891TruDi NAV SuctionTDNS090ZTDNS090Z2019-01-20
20705031245867TruDi NAV CableTDNC001ZTDNC001Z2018-10-31
10705031200258RELIEVA ULTIRRABC0516RUBC0516RU2016-10-01
10705031200272RELIEVA ULTIRRABC0616RUBC0616RU2016-10-01
10705031200289RELIEVA ULTIRRABC0716RUBC0716RU2016-10-01
10705031200296RELIEVA ULTIRRABC0724RUBC0724RU2016-10-01
10705031063549RELIEVA SIDEKICK LPSDKKLPSDKKLP2016-10-01
10705031205871RELIEVA VORTEX 2RV02RV022016-10-01
10705031237087ACCLARENT NAVWIREGW35150NZGW35150NZ2017-08-01
10705031238701RELIEVA ULTIRRA NAVBC0516RUNBC0516RUN2017-08-01
10705031241008RELIEVA SPINPLUS NAVRSP0516MFSNRSP0516MFSN2018-02-09
10705031241015RELIEVA SPINPLUS NAVRSP0616MFSNRSP0616MFSN2018-02-18
10705031245907TruDi NAVWIRETDNW001TDNW0012019-10-20
10705031462588RELIEVA TRACTRT1040ART1040A2019-05-31
10705031462601RELIEVA TRACTRT1240ART1240A2019-05-31
10705031462625RELIEVA TRACTRT1440ART1440A2019-05-31
10705031462649RELIEVA TRACTRT1640ART1640A2019-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260759931697VirtuEye ProFiagon GmbHPGW2026-08-17
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2026-08-07
04589551366217P300-2A100NAKANISHI INC.ERL2026-06-26
04589551366262P300-2A120NAKANISHI INC.ERL2026-06-26
04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.ERL2026-06-26
04056481146702Curve NavigationBrainlab SEPGW2025-10-13
00821925033900DIEGOGyrus ACMI, LLCERL2024-07-25
00821925033917DIEGOGyrus ACMI, LLCERL2024-07-24
00821925034419DIEGOGyrus ACMI, LLCERL2024-07-23
04056481144500Curve Navigation 17700Brainlab SEPGW2023-05-22
04056481144685Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mmBrainlab SEPGW2023-05-05
04056481144692Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation ScrewBrainlab SEPGW2023-05-05
04056481143725Kick 2 Navigation Station EMBrainlab SEPGW2022-09-30
07613327501292iBurSTRYKER CORPORATIONERL2021-08-12
07613327501308iBurSTRYKER CORPORATIONERL2021-08-12
07613327504019NASTRYKER CORPORATIONERL2021-07-08
07613327512298N / AStryker Leibinger GmbH & Co. KGPGW2020-12-04
07613327512304N / AStryker Leibinger GmbH & Co. KGPGW2020-11-26
04056481142520Curve Navigation 17700Brainlab SEPGW2020-05-25
07613327482423n/aStryker Leibinger GmbH & Co. KGPGW2019-10-25
04056481140410EM Short PointerBrainlab SEPGW2019-07-16
04048551387344n.a.Karl Storz GmbH & Co. KGPGW2019-02-23
10887587057026NASynthes GmbHERL2019-02-22
10705031245877TruDi NAV SuctionACCLARENT, INC.PGW2019-01-20
10705031245884TruDi NAV SuctionACCLARENT, INC.PGW2019-01-20
10705031245891TruDi NAV SuctionACCLARENT, INC.PGW2019-01-20
07613327423631CORESTRYKER CORPORATIONERL2018-12-11
10705031245853TruDi NAV CableACCLARENT, INC.PGW2018-10-31
20705031245867TruDi NAV CableACCLARENT, INC.PGW2018-10-31