B-P TOTAL SHOULDER SYSTEM 02-02-5456

GUDID 00814193025272

B-P SHOULDER GLENOID BEARING SIZE 4, 5 MM THICKNESS, 56 MM HUMERAL HEAD

ENDOTEC, INC.

Total shoulder prosthesis

Primary Device ID	00814193025272
NIH Device Record Key	07bb8d42-cfea-49fc-a4fe-706d7244b87b
Commercial Distribution Status	In Commercial Distribution
Brand Name	B-P TOTAL SHOULDER SYSTEM
Version Model Number	02-02-5456
Catalog Number	02-02-5456
Company DUNS	803488357
Company Name	ENDOTEC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
Width	5 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Outer Diameter	56 Millimeter
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Operating and Storage Conditions

Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814193025272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K904879

FDA Product Code

KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-17

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

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