B-P TOTAL HIP SYSTEM 01-16-0819

GUDID 00814193024749

B-P MODULAR EXTENSION W/ULTRACOAT - 19 MM X 200 MM

ENDOTEC, INC.

Humeral head bipolar component Humeral head bipolar component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component Bipolar humeral head outer component
Primary Device ID00814193024749
NIH Device Record Keyd6972b19-ccd6-424c-b3dd-ce0ed4d1ff83
Commercial Distribution StatusIn Commercial Distribution
Brand NameB-P TOTAL HIP SYSTEM
Version Model Number01-16-0819
Catalog Number01-16-0819
Company DUNS803488357
Company NameENDOTEC, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width19 Millimeter
Width19 Millimeter
Width19 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter
Length200 Millimeter
Width19 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100814193024749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-17

On-Brand Devices [B-P TOTAL HIP SYSTEM ]

00814193024930B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM + 20 MM
00814193024923B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 20 MM
00814193024916B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM + 15 MM
00814193024909B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 15 MM
00814193024893B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM + 10 MM
00814193024886B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 10 MM
00814193024879B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM + 5 MM
00814193024862B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 5 MM
00814193024855B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 1 MM
00814193024848B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM STD
00814193024831B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 16 MM
00814193024824B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 15 MM
00814193024817B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 14 MM
00814193024800B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 13 MM
00814193024794B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 12 MM
00814193024787B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 11 MM
00814193024770B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 10 MM
00814193024763B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCOAT & W/ULTRACOAT - 9 MM
00814193024756B-P MODULAR EXTENSION W/ULTRACOAT - 20 MM X 200 MM
00814193024749B-P MODULAR EXTENSION W/ULTRACOAT - 19 MM X 200 MM
00814193024732B-P MODULAR EXTENSION W/ULTRACOAT - 18 MM X 200 MM
00814193024725B-P MODULAR EXTENSION W/ULTRACOAT - 17 MM X 200 MM
00814193024718B-P MODULAR EXTENSION W/ULTRACOAT - 16 MM X 200 MM
00814193024701B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 200 MM
00814193024695B-P MODULAR EXTENSION W/ULTRACOAT - 14 MM X 200 MM
00814193024688B-P MODULAR EXTENSION W/ULTRACOAT - 13 MM X 200 MM
00814193024671B-P MODULAR EXTENSION W/ULTRACOAT - 12 MM X 200 MM
00814193024664B-P MODULAR EXTENSION W/ULTRACOAT - 11 MM X 200 MM
00814193024657B-P MODULAR EXTENSION W/ULTRACOAT - 10 MM X 200 MM
00814193024640B-P MODULAR EXTENSION W/ULTRACOAT - 9 MM X 200 MM
00814193024633B-P MODULAR EXTENSION W/ULTRACOAT - 20 MM X 175 MM
00814193024626B-P MODULAR EXTENSION W/ULTRACOAT - 19 MM X 175 MM
00814193024619B-P MODULAR EXTENSION W/ULTRACOAT - 18 MM X 175 MM
00814193024602B-P MODULAR EXTENSION W/ULTRACOAT - 17 MM X 175 MM
00814193024596B-P MODULAR EXTENSION W/ULTRACOAT - 16 MM X 175 MM
00814193024589B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 175 MM
00814193024572B-P MODULAR EXTENSION W/ULTRACOAT - 14 MM X 175 MM
00814193024565B-P MODULAR EXTENSION W/ULTRACOAT - 13 MM X 175 MM
00814193024558B-P MODULAR EXTENSION W/ULTRACOAT - 12 MM X 175 MM
00814193024541B-P MODULAR EXTENSION W/ULTRACOAT - 11 MM X 175 MM
00814193024534B-P MODULAR EXTENSION W/ULTRACOAT - 10 MM X 175 MM
00814193024527B-P MODULAR EXTENSION W/ULTRACOAT - 9 MM X 175 MM
00814193024510B-P MODULAR EXTENSION W/ULTRACOAT - 20 MM X 150 MM
00814193024503B-P MODULAR EXTENSION W/ULTRACOAT - 19 MM X 150 MM
00814193024497B-P MODULAR EXTENSION W/ULTRACOAT - 18 MM X 150 MM
00814193024480B-P MODULAR EXTENSION W/ULTRACOAT - 17 MM X 150 MM
00814193024473B-P MODULAR EXTENSION W/ULTRACOAT - 16 MM X 150 MM
00814193024466B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 150 MM
00814193024459B-P MODULAR EXTENSION W/ULTRACOAT - 14 MM X 150 MM
00814193024442B-P MODULAR EXTENSION W/ULTRACOAT - 13 MM X 150 MM

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