FLUSH HEALING SCREW 5.0 FLUSH HS

GUDID D78550FLUSHHS0

5.0mm FLUSH HEALING SCREW

OCO BIOMEDICAL INC

Dental implant suprastructure, temporary, preformed, single-use
Primary Device IDD78550FLUSHHS0
NIH Device Record Key1e05212d-92ca-4b63-a2be-a5ff03c626b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLUSH HEALING SCREW
Version Model Number5.0mm FLUSH HEALING SCREW
Catalog Number5.0 FLUSH HS
Company DUNS094146123
Company NameOCO BIOMEDICAL INC
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 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
HIBCCD78550FLUSHHS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


[D78550FLUSHHS0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-23
Device Publish Date2024-02-15

On-Brand Devices [FLUSH HEALING SCREW]

D78550FLUSHHS05.0mm FLUSH HEALING SCREW
D785325FLUSHHS03.25mm FLUSH HEALING SCREW

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