UF(II) Wide UF(II) 7013SF

GUDID 08800049228920

DIO Corporation

Screw endosteal dental implant, two-piece
Primary Device ID08800049228920
NIH Device Record Key5228beb3-10f6-4597-8530-401a08b3ece5
Commercial Distribution StatusIn Commercial Distribution
Brand NameUF(II) Wide
Version Model NumberUF(II) 7013SF
Catalog NumberUF(II) 7013SF
Company DUNS631085206
Company NameDIO Corporation
Device Count1
DM Exempttrue
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108800049228920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-09
Device Publish Date2022-03-01

On-Brand Devices [UF(II) Wide]

08806195981849UF(II) 7013SF
08806195981832UF(II) 7011SF
08806195981825UF(II) 7010SF
08806195981818UF(II) 7008SF
08806195981801UF(II) 7007SF
08806195981795UF(II) 6513SF
08806195981788UF(II) 6511SF
08806195981771UF(II) 6510SF
08806195981764UF(II) 6508SF
08806195981757UF(II) 6507SF
08806195981740UF(II) 6013SF
08806195981733UF(II) 6011SF
08806195981726UF(II) 6010SF
08806195981719UF(II) 6008SF
08806195981702UF(II) 6007SF
08806195934579UF(II) 7013S
08806195934562UF(II) 7011S
08806195934555UF(II) 7010S
08806195934548UF(II) 7008S
08806195934531UF(II) 7007S
08806195934500UF(II) 6513S
08806195934494UF(II) 6511S
08806195934487UF(II) 6510S
08806195934470UF(II) 6508S
08806195934463UF(II) 6507S
08806195934432UF(II) 6013S
08806195934425UF(II) 6011S
08806195934418UF(II) 6010S
08806195934401UF(II) 6008S
08806195934395UF(II) 6007S
08800049228920UF(II) 7013SF
08800049228906UF(II) 7013S
08800049228852UF(II) 7011SF
08800049228838UF(II) 7011S
08800049228784UF(II) 7010SF
08800049228760UF(II) 7010S
08800049228715UF(II) 7008SF
08800049228692UF(II) 7008S
08800049228647UF(II) 7007SF
08800049228623UF(II) 7007S
08800049228449UF(II) 6513SF
08800049228425UF(II) 6513S
08800049228371UF(II) 6511SF
08800049228357UF(II) 6511S
08800049228302UF(II) 6510SF
08800049228289UF(II) 6510S
08800049228234UF(II) 6508SF
08800049228210UF(II) 6508S
08800049228166UF(II) 6507SF
08800049228142UF(II) 6507S

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