SURGICAL KIT KTMEC 02

GUDID 07899995209511

PROSTHETIC KIT

Sin Sistema de Implante Nacional S/A

Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID07899995209511
NIH Device Record Keyc7b78ec3-8fdb-4e43-8d42-a719498f6793
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGICAL KIT
Version Model NumberKTMEC 02
Catalog NumberKTMEC 02
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
GS107899995209511 [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

[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

Moist Heat or Steam Sterilization


[07899995209511]

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 KIT]

07899995299949SURGICAL KIT UNITITE
07899995299932GUIDED SURGERY KIT UNITITE
07899995299918GUIDED SURGERY KIT STRONG SW
07899995294555KIT SAFE DRILL
07899995294548KIT SAFE DRILL SW
07899995293565SURGERY KIT TRYON
07899995271471SURGICAL KIT TRYON
07899995269942KIT SINUS LIFTING
07899995209528SURGICAL KIT ZYGOMATIC
07899995209511PROSTHETIC KIT
07899995209412KITS OSTEOTOMER RUMMERR C/STOP
07899995209368KIT BONE EXPANDER WITH STOPPER
07899995209306SURGICAL KIT STRONG SW
07899995209290KIT ROTARY EXPANDER

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