4mm Offset Shielded 15 Degree Abutment 4250 TSI L

GUDID D7854250TSIL0

4mm Diameter Offset Shielded 15 Degree Abutment Long

OCO BIOMEDICAL INC

Dental implant system
Primary Device IDD7854250TSIL0
NIH Device Record Keyd7a2165a-7424-42db-bf96-499588bd136d
Commercial Distribution StatusIn Commercial Distribution
Brand Name4mm Offset Shielded 15 Degree Abutment
Version Model NumberOffset Shielded 15 Degree Abutment
Catalog Number4250 TSI L
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 Numbertrue
Manufacturing Datefalse
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
HIBCCD7854250TSIL0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


[D7854250TSIL0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-03-22

On-Brand Devices [4mm Offset Shielded 15 Degree Abutment]

D7854250TSIS04mm Diameter Offset Shielded 15 Degree Abutment Short
D7854250TSIL04mm Diameter Offset Shielded 15 Degree Abutment Long

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