FDA.report

TruDi Shaver Blade

Primary DI
20705031469232
Brand
TruDi Shaver Blade
Company
ACCLARENT, INC.
Model
TSB4STR
Catalog number
TSB4STR
Device description
Trudi Shaver Blade 4.0mm - Straight (0°)- 5pk
Published
2022-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PGWEar, Nose, and Throat Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Premarket Submissions

SubmissionSupplement
K221037000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K221037000TruDi Shaver BladeAcclarent, Inc.2022-07-20PGW

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20705031469232PackageGS15In Commercial Distribution
10705031469235PrimaryGS10

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods

Method

Contacts

PhoneEmail
+1(650)687-5888xx@xx.xx
+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

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10705031245891TruDi NAV SuctionTDNS090ZTDNS090Z2019-01-20
20705031469218TruDi Shaver BladeTSB460TSB4602022-09-09
20705031469249TruDi Shaver BladeTSB3STRTSB3STR2022-09-09
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20705031469294TruDi Shaver BladeTSB415TSB4152022-09-09
20705031469225TruDi Shaver BladeTSB4STRZTSB4STRZ2022-09-09
20705031469256TruDi Shaver BladeTSB3STRZTSB3STRZ2022-09-09
20705031469263TruDi Shaver BladeTSB440ZTSB440Z2022-09-09
20705031469287TruDi Shaver BladeTSB415ZTSB415Z2022-09-09
20705031469300TruDi Shaver BladeTSB460ZTSB460Z2022-09-09
20705031465562ACCLARENT PIVOTPVT0616PVT06162020-10-01
20705031465579ACCLARENT PIVOTPVT0616LPVT0616L2020-10-01
20705031465593ACCLARENT PIVOTPVT0616NPVT0616N2020-10-01
20705031465586ACCLARENT PIVOTPVT0616LZPVT0616LZ2020-10-01
20705031465609ACCLARENT PIVOTPVT0616NZPVT0616NZ2020-10-01
20705031465616ACCLARENT PIVOTPVT0616ZPVT0616Z2020-10-01
20705031465425TruDi CuretteTDC0005TDC00052020-08-31
20705031465432TruDi CuretteTDC0005ZTDC0005Z2020-08-31

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