SURGICAL KIT ZYGOMATIC KZ 01

GUDID 07899995264244

SURGICAL KIT ZYGOMATIC

Sin Sistema de Implante Nacional S/A

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID07899995264244
NIH Device Record Keyfec6d71e-d5d9-4619-b214-87d6b500cb2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGICAL KIT ZYGOMATIC
Version Model NumberKZ 01
Catalog NumberKZ 01
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107899995264244 [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

[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


[07899995264244]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-06
Device Publish Date2023-10-27

Devices Manufactured by Sin Sistema de Implante Nacional S/A

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07899995243812 - DRIVER RATCHET HEX1.4 LONG ANG.2025-12-31 DRIVER RATCHET HEX1.4 LONG ANG.
07899995243829 - DRIVER RATCHET HEX1.4 MEDIUM ANG.2025-12-31 DRIVER RATCHET HEX1.4 MEDIUM ANG.
07899995243836 - DRIVER RATCHET HEX1.4 SHORT ANG.2025-12-31 DRIVER RATCHET HEX1.4 SHORT ANG.
07899995243843 - DRIVER HANDP. HEX.1.4MM EXT. LONG ANG.2025-12-31 DRIVER HANDP. HEX.1.4MM EXT. LONG ANG.
07899995243850 - DRIVER HANDPIECE HEX.1.4MM LONG ANG.2025-12-31 DRIVER HANDPIECE HEX.1.4MM LONG ANG.
07899995243874 - DRIVER HANDPIECE HEX.1.4MM MEDIUM ANG.2025-12-31 DRIVER HANDPIECE HEX.1.4MM MEDIUM ANG.
07899995243881 - DRIVER HANDPIECE HEX.1.4MM SHORT ANG.2025-12-31 DRIVER HANDPIECE HEX.1.4MM SHORT ANG.

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