FDA.report

TruDi Curette

Primary DI
20705031465432
Brand
TruDi Curette
Company
ACCLARENT, INC.
Model
TDC0005Z
Catalog number
TDC0005Z
Device description
TruDi Curette, 0°, 5IN - 1PK
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

Related Records

Product Codes

CodeName
PGWEar, Nose, and Throat Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Premarket Submissions

SubmissionSupplement
K201174000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K201174000TruDi CuretteAcclarent, Inc.2020-08-12PGW

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20705031465432PrimaryGS10

GMDN Terms

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

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

Sterilization Methods

Method

Contacts

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

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20705031469218TruDi Shaver BladeTSB460TSB4602022-09-09
20705031469232TruDi Shaver BladeTSB4STRTSB4STR2022-09-09
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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
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20705031465579ACCLARENT PIVOTPVT0616LPVT0616L2020-10-01
20705031465593ACCLARENT PIVOTPVT0616NPVT0616N2020-10-01
20705031465586ACCLARENT PIVOTPVT0616LZPVT0616LZ2020-10-01
20705031465609ACCLARENT PIVOTPVT0616NZPVT0616NZ2020-10-01
20705031465616ACCLARENT PIVOTPVT0616ZPVT0616Z2020-10-01
20705031465425TruDi CuretteTDC0005TDC00052020-08-31

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