FDA.reportPublic FDA data

NA

Primary DI
10705034485416
Brand
NA
Company
DEPUY SPINE, LLC
Model
698342041
Catalog number
698342041
Device description
MODIFIED INSTRUMENT DOWN BITING CURETTE
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTFCURETTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034485416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503448541610705034485416

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical curette, single-useA hand-held manual surgical instrument intended to be used to scrape and debride tissue from a bone surface (e.g., cancellous vertebral bone of the spine) or a cavity wall during a neurosurgical procedure. It consists of a long, thin, metal shaft that terminates distally into a spoon-, scoop- or mushroom-like cutting head, that can be set at alternative angles, which enables a smooth scoring action for the creation of grooves or channels. It is typically used during percutaneous kyphoplasty to treat vertebral compression fractures (VCFs), or during craniotomy or brain microsurgery. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
107105876
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034197845BENGAL2773171002773171002016-12-31
10705034197869BENGAL2773173002773173002016-12-31
10705034197890BENGAL2773175102773175102016-12-31
10705034197906BENGAL2773176002773176002016-12-31
10705034197920BENGAL2773188002773188002016-12-31
10705034197937BENGAL2773189002773189002016-12-31
10705034222424MOUNTAINEER2883905002883905002016-12-31
10705034222486MOUNTAINEER2883907002883907002016-12-31
10705034471716N/A6983411716983411712022-10-07
10705034570105N\A6983447336983447332022-10-07
10705034570211N/A6983447246983447242022-10-07
10705034570228N\A6983447346983447342022-10-07
10705034570433N/A6983447266983447262022-10-07
10705034570501N\A6983447326983447322022-10-07
10705034570624N/A6983447286983447282022-10-07
10705034570693N\A6983447316983447312022-10-07
10705034570723N/A6983447276983447272022-10-07
10705034458267N/A6983393806983393802022-02-02
10705034579139N/A6983451326983451322026-03-20
10705034579146N/A6983451336983451332026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704941692PILLINGTELEFLEX INCORPORATEDHTF2026-03-23
24026704941708PILLINGTELEFLEX INCORPORATEDHTF2026-03-23
00192896122871Spoon CuretteSONTEC INSTRUMENTS, INC.HTF2026-03-19
00810158219052PRINCETONPrinceton Medical Group, Inc.HTF2026-03-11
00190776393229MillenniumAvalign Technologies, Inc.HTF2026-03-04
00810168190297NAPACIFIC INSTRUMENTS, INC.HTF2026-03-03
00190776417260MillenniumAvalign Technologies, Inc.HTF2026-02-20
00190776416447MillenniumAvalign Technologies, Inc.HTF2026-02-16
00190776416669MillenniumAvalign Technologies, Inc.HTF2026-02-16
03662663109475Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109512Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109529Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109543Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109550Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109567Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
00190776416010MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416027MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416041MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416058MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416065MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776415785MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415792MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415808MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415815MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415822MillenniumAvalign Technologies, Inc.HTF2026-02-04
03662663083584ActivLHighridge Medical, LLCHTF2026-02-03
03662663083591ActivLHighridge Medical, LLCHTF2026-02-03
03662663083607ActivLHighridge Medical, LLCHTF2026-02-03
03662663083614ActivLHighridge Medical, LLCHTF2026-02-03
03662663083621ActivLHighridge Medical, LLCHTF2026-02-03