FDA.reportPublic FDA data

TruDi Shaver Blade

Primary DI
20705031469300
Brand
TruDi Shaver Blade
Company
ACCLARENT, INC.
Model
TSB460Z
Catalog number
TSB460Z
Device description
Trudi Shaver Blade 4.0mm - 60° Curved - 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
20705031469300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503146930020705031469300

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
10381780544197TruDi®TSB3STRTSB3STR2026-11-03
10381780544210TruDi®TSB415TSB4152026-11-03
10381780544234TruDi®TSB440TSB4402026-11-03
10381780544258TruDi®TSB460TSB4602026-11-03
10381780544272TruDi®TSB4STRTSB4STR2026-11-03
10705031230880ACCLARENT AERAEU061655EU0616552016-11-17
20705031230870ACCLARENT AERAEU061655ZEU061655Z2016-11-05
10381780544081TruDi®TDNC001TDNC0012026-10-15
10705031063297INSPIRA AIRBC1040ABC1040A2016-09-01
10705031063310INSPIRA AIRBC1440ABC1440A2016-09-01
10705031131996INSPIRA AIRBC0524ABC0524A2016-09-01
10705031132061INSPIRA AIRBC0724ABC0724A2016-09-01
10705031147737INSPIRA AIRBC1240ABC1240A2016-09-01
10705031147744INSPIRA AIRBC1640ABC1640A2016-09-01
10705031206052INSPIRA AIRBC8524ABC8524A2016-09-01
20705031063089INSPIRA AIRBC0524AZBC0524AZ2016-09-01
20705031063126INSPIRA AIRBC0724AZBC0724AZ2016-09-01
20705031063157INSPIRA AIRBC1040AZBC1040AZ2016-09-01
20705031063171INSPIRA AIRBC1440AZBC1440AZ2016-09-01
20705031147703INSPIRA AIRBC1240AZBC1240AZ2018-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780544197TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544197TruDi®ACCLARENT, INC.ERL2026-11-03
10381780544210TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544210TruDi®ACCLARENT, INC.ERL2026-11-03
10381780544234TruDi®ACCLARENT, INC.ERL2026-11-03
10381780544234TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544258TruDi®ACCLARENT, INC.ERL2026-11-03
10381780544258TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544272TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544272TruDi®ACCLARENT, INC.ERL2026-11-03
00824846012832StealthMEDTRONIC NAVIGATION, INC.PGW2026-10-30
00763000945817ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945824ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945831ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945848ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945855ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000957858ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
10381780544081TruDi®ACCLARENT, INC.PGW2026-10-15
04260759931314Flexarm UniversalFiagon GmbHPGW2026-09-20
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
J021305020241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-07-08
00821925033900DIEGOGyrus ACMI, LLCERL2024-07-25
00821925033917DIEGOGyrus ACMI, LLCERL2024-07-24
00821925034419DIEGOGyrus ACMI, LLCERL2024-07-23