FDA.reportPublic FDA data

TruDi®

Primary DI
10381780544234
Brand
TruDi®
Company
ACCLARENT, INC.
Model
TSB440
Catalog number
TSB440
Device description
TruDi® Shaver Blade - 4mm Shaft Diameter, 40° Angle
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
30381780544238PackageGS15In Commercial Distribution
30381780544245PackageGS11In Commercial Distribution
10705031469273PreviousGS10
10381780544234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178054423830381780544238
3038178054424530381780544245
1070503146927310705031469273
1038178054423410381780544234

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged, Keep away from sunlight, Keep dry

Contacts#

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

Regulatory Flags#

DUNS number
361092450
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780544197TruDi®TSB3STRTSB3STR2026-11-03
10381780544210TruDi®TSB415TSB4152026-11-03
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
20705031242682INSPIRA AIRBC8524AZBC8524AZ2018-03-31

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
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
04056481144500Curve Navigation 17700Brainlab SEPGW2023-05-22
04056481144685Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mmBrainlab SEPGW2023-05-05