SURGICAL INSTRUMENT KSDSW

GUDID 07899995209450

KIT SHORT DRILLS SW

Sin Sistema de Implante Nacional S/A

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Primary Device ID07899995209450
NIH Device Record Keyd6632799-4128-480a-8bc0-6603fd87b4c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGICAL INSTRUMENT
Version Model NumberKSDSW
Catalog NumberKSDSW
Company DUNS904569092
Company NameSin Sistema de Implante Nacional S/A
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107899995209450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


[07899995209450]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [SURGICAL INSTRUMENT]

07899995296320SURGICAL HAMMER
07899995270122MALE DRILL Ø4,0MM
07899995270115MALE DRILL Ø6,0MM
07899995270108MALE DRILL Ø5,0MM
07899995209856MALE THREAD IMP 3.25
07899995206411DRIVER HANDPIECE UNITITE COMPACT LONG
07899995206404DRIVER HANDPIECE UNITITE COMPACT SHORT
07899995205445MALE DRILL Ø 5,0MM
07899995205438MALE DRILL Ø 4,3MM
07899995205421MALE DRILL Ø 3,5MM
07899995205407MALE DRILL Ø 2,9MM
07899995205094DRIVER HAND HEX 1.2X24
07899995215109PROSTHETIC TORQUE FIXER
07899995213631OSTEOTOME SUMMER W/ STOP N 4
07899995213624OSTEOTOME SUMMER W/ STOP N 3
07899995213617OSTEOTOME SUMMER W/ STOP N 2
07899995213600OSTEOTOME SUMMER W/ STOP N 1
07899995213594DEPTH ROUNDER STRAIGHT
07899995213587DEPTH ROUNDER ANGULATED
07899995211538LONG LIP PROTECTOR
07899995211521SHORT LIP PROTECTOR
07899995208651DRILL SPHERICAL Ø3.0
07899995208514DRILL PILOT ZYGOMATIC
07899995208408DRILL HELICAL ZYGOMATIC Ø3.55
07899995208392DRILL HELICAL ZYGOMATIC Ø2.95
07899995207364DRIVER HANDPIECE C. MORSE LONG
07899995207340DRIVER HANDPIECE C. MORSE
07899995207319ROTARY EXPANDER N 04
07899995207302ROTARY EXPANDER N 03
07899995207296ROTARY EXPANDER N 02
07899995207289ROTARY EXPANDER N 01
07899995206800DRIVER HANDPIECE UNITIE SLIM LONG
07899995206749DRIVER HANDPIECE UNITITE SLIM SHORT
07899995206435DRIVER HANDPIECE UNITITE MORSE LONG
07899995206428DRIVER HANDPIECE UNITITE MORSE SHORT
07899995206374MALE DRILL IMP Ø5,0MM
07899995206367MALE DRILL IMP Ø4,5MM
07899995206350MALE DRILL IMP Ø3,8MM
07899995206343MALE DRILL IMP Ø3,75MM
07899995206336MALE DRILL IMP Ø3,5MM
07899995205506DRIVER SQUARE TORQUE 24
07899995205490DRIVE SQUARE TORQUE 20
07899995205483DRIVE HANDPIECE
07899995205476PROSTHETIC DRUM
07899995205452DRIVER HANDS IMPLANT ZYGOMATIC
07899995205377DRIVER HANDPIECE LONG HEX. INTER
07899995205360DRIVER HANDPIECE SHORTY HEX. INTER
07899995205292DRIVER SQUARE TORQUE 24
07899995205155DRIVER TORQUE HEX. 1.2X24
07899995205148DRIVER TORQUE HEX. 1.2X20

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