IU SB Abutment_Non hex Φ4.0

GUDID 08800026104223

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026104223
NIH Device Record Keyd8da90f6-f731-4881-9078-459a4a6563fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU SB Abutment_Non hex Φ4.0
Version Model NumberIUSB4035NA
Company DUNS688857820
Company NameWARANTEC.Co.,Ltd
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS108800026104223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


[08800026104223]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-20
Device Publish Date2023-04-12

On-Brand Devices [IU SB Abutment_Non hex Φ4.0]

08800026109402IUSB4064NA
08800026109396IUSB4064N
08800026109389IUSB4054NA
08800026109372IUSB4054N
08800026109365IUSB4044NA
08800026109358IUSB4044N
08800026109341IUSB4034NA
08800026109334IUSB4034N
08800026109327IUSB4024NA
08800026109310IUSB4024N
08800026109303IUSB4014NA
08800026109297IUSB4014N
08800026104292IUSB4067NA
08800026104285IUSB4065NA
08800026104278IUSB4057NA
08800026104261IUSB4055NA
08800026104254IUSB4047NA
08800026104247IUSB4045NA
08800026104230IUSB4037NA
08800026104223IUSB4035NA
08800026104216IUSB4027NA
08800026104209IUSB4025NA
08800026104193IUSB4017NA
08800026104186IUSB4015NA
08800026103936IUSB4067N
08800026103929IUSB4065N
08800026103912IUSB4057N
08800026103905IUSB4055N
08800026103899IUSB4047N
08800026103882IUSB4045N
08800026103875IUSB4037N
08800026103868IUSB4035N
08800026103851IUSB4027N
08800026103844IUSB4025N
08800026103837IUSB4017N
08800026103820IUSB4015N

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