B-P TOTAL SHOULDER SYSTEM 02-02-2252

GUDID 00814193025104

B-P SHOULDER GLENOID BEARING SIZE 2, 2.5 MM THICKNESS, 52 MM HUMERAL HEAD

ENDOTEC, INC.

Total shoulder prosthesis
Primary Device ID00814193025104
NIH Device Record Keyd3612fe5-37c4-409c-abba-20716bf74344
Commercial Distribution StatusIn Commercial Distribution
Brand NameB-P TOTAL SHOULDER SYSTEM
Version Model Number02-02-2252
Catalog Number02-02-2252
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

Outer Diameter52 Millimeter
Outer Diameter52 Millimeter
Outer Diameter52 Millimeter
Outer Diameter52 Millimeter
Outer Diameter52 Millimeter
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 Millimeter
Width2.5 Millimeter
Device Size Text, specify0
Outer Diameter52 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814193025104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSProsthesis, Shoulder, 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 SHOULDER SYSTEM ]

00814193025562B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 4
00814193025555B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 3
00814193025548B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 2
00814193025531B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 1
00814193025524B-P SHOULDER MODULAR HUMERAL STEM W/O HEAD W/BIOCOAT & W/ULTRACOAT - 12 MM
00814193025517B-P SHOULDER HUMERAL HEAD EXTENSION W/ULTRACOAT - 10 MM
00814193025500B-P SHOULDER HUMERAL HEAD EXTENSION W/ULTRACOAT - 7.5 MM
00814193025494B-P SHOULDER HUMERAL HEAD EXTENSION W/ULTRACOAT - 5 MM
00814193025487B-P SHOULDER HUMERAL HEAD EXTENSION W/ULTRACOAT - 2.5 MM
00814193025470B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 14 MM
00814193025463B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 12 MM
00814193025456B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 10 MM
00814193025449B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 8 MM
00814193025432B-P SHOULDER HUMERAL HEAD W/ ULTRACOAT - 52 MM
00814193025425B-P SHOULDER HUMERAL HEAD W/ ULTRACOAT - 48 MM
00814193025418B-P SHOULDER HUMERAL HEAD W/ ULTRACOAT - 44 MM
00814193025401B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT - 14 MM
00814193025395B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT - 12 MM
00814193025388B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT - 10 MM
00814193025371B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT - 8 MM
00814193025364B-P SHOULDER HUMERAL STEM W/O HEAD W/ BIOCOAT & W/ULTRACOAT - 14 MM
00814193025357B-P SHOULDER HUMERAL STEM W/O HEAD W/ BIOCOAT & W/ULTRACOAT - 12 MM
00814193025340B-P SHOULDER HUMERAL STEM W/O HEAD W/ BIOCOAT & W/ULTRACOAT - 10 MM
00814193025333B-P SHOULDER HUMERAL STEM W/O HEAD W/ BIOCOAT & W/ULTRACOAT - 8 MM
00814193025326B-P SHOULDER HUMERAL RESURFACING HEAD W/BIOCOAT & W/ULTRACOAT - 56 MM
00814193025319B-P SHOULDER HUMERAL RESURFACING HEAD W/BIOCOAT & W/ULTRACOAT - 52 MM
00814193025302B-P SHOULDER HUMERAL RESURFACING HEAD W/BIOCOAT & W/ULTRACOAT - 48 MM
00814193025296B-P SHOULDER HUMERAL RESURFACING HEAD W/BIOCOAT & W/ULTRACOAT - 44 MM
00814193025289B-P SHOULDER HUMERAL RESURFACING HEAD W/BIOCOAT & W/ULTRACOAT - 40 MM
00814193025272B-P SHOULDER GLENOID BEARING SIZE 4, 5 MM THICKNESS, 56 MM HUMERAL HEAD
00814193025265B-P SHOULDER GLENOID BEARING SIZE 4, 5 MM THICKNESS, 52 MM HUMERAL HEAD
00814193025258B-P SHOULDER GLENOID BEARING SIZE 4, 5 MM THICKNESS, 48 MM HUMERAL HEAD
00814193025241B-P SHOULDER GLENOID BEARING SIZE 4, 5 MM THICKNESS, 44 MM HUMERAL HEAD
00814193025234B-P SHOULDER GLENOID BEARING SIZE 3, 5 MM THICKNESS, 52 MM HUMERAL HEAD
00814193025227B-P SHOULDER GLENOID BEARING SIZE 3, 5 MM THICKNESS, 48 MM HUMERAL HEAD
00814193025210B-P SHOULDER GLENOID BEARING SIZE 3, 5 MM THICKNESS, 44 MM HUMERAL HEAD
00814193025203B-P SHOULDER GLENOID BEARING SIZE 2, 5 MM THICKNESS, 52 MM HUMERAL HEAD
00814193025197B-P SHOULDER GLENOID BEARING SIZE 2, 5 MM THICKNESS, 48 MM HUMERAL HEAD
00814193025180B-P SHOULDER GLENOID BEARING SIZE 2, 5 MM THICKNESS, 44 MM HUMERAL HEAD
00814193025173B-P SHOULDER GLENOID BEARING SIZE 4, 2.5 MM THICKNESS, 56 MM HUMERAL HEAD
00814193025166B-P SHOULDER GLENOID BEARING SIZE 4, 2.5 MM THICKNESS, 52 MM HUMERAL HEAD
00814193025159B-P SHOULDER GLENOID BEARING SIZE 4, 2.5 MM THICKNESS, 48 MM HUMERAL HEAD
00814193025142B-P SHOULDER GLENOID BEARING SIZE 4, 2.5 MM THICKNESS, 44 MM HUMERAL HEAD
00814193025135B-P SHOULDER GLENOID BEARING SIZE 3, 2.5 MM THICKNESS, 52 MM HUMERAL HEAD
00814193025128B-P SHOULDER GLENOID BEARING SIZE 3, 2.5 MM THICKNESS, 48 MM HUMERAL HEAD
00814193025111B-P SHOULDER GLENOID BEARING SIZE 3, 2.5 MM THICKNESS, 44 MM HUMERAL HEAD
00814193025104B-P SHOULDER GLENOID BEARING SIZE 2, 2.5 MM THICKNESS, 52 MM HUMERAL HEAD
00814193025098B-P SHOULDER GLENOID BEARING SIZE 2, 2.5 MM THICKNESS, 48 MM HUMERAL HEAD
00814193025081B-P SHOULDER GLENOID BEARING SIZE 2, 2.5 MM THICKNESS, 44 MM HUMERAL HEAD
00814193025074B-P SHOULDER GLENOID BEARING SIZE 4, 0 MM THICKNESS, 56 MM HUMERAL HEAD

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