FDA.reportPublic FDA data

TruDi Curette

Primary DI
20705031465425
Brand
TruDi Curette
Company
ACCLARENT, INC.
Model
TDC0005
Catalog number
TDC0005
Device description
TruDi Curette-0deg - 5PK
Published
2020-08-31
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
PGWEar, Nose, and Throat Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201174000TruDi CuretteAcclarent, Inc.2020-08-12PGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031465425PackageGS15In Commercial Distribution
10705031465428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503146542520705031465425
1070503146542810705031465428

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, single-useA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. 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)687-5888xxx@xxx.xxx
+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
10705031063549RELIEVA SIDEKICK LPSDKKLPSDKKLP2016-10-01
10705031200258RELIEVA ULTIRRABC0516RUBC0516RU2016-10-01
10705031200272RELIEVA ULTIRRABC0616RUBC0616RU2016-10-01
10705031200289RELIEVA ULTIRRABC0716RUBC0716RU2016-10-01
10705031200296RELIEVA ULTIRRABC0724RUBC0724RU2016-10-01
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
20705031462592RELIEVA TRACTRT1040AZRT1040AZ2019-05-31
20705031462615RELIEVA TRACTRT1240AZRT1240AZ2019-05-31
20705031462639RELIEVA TRACTRT1440AZRT1440AZ2019-05-31
20705031462653RELIEVA TRACTRT1640AZRT1640AZ2019-05-31
20705031245911TruDi NAVWIRETDNW001ZTDNW001Z2019-10-20

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Primary DI, Brand, Company table
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