B-P TOTAL SHOULDER SYSTEM 02-04-0114

GUDID 00814193025364

B-P SHOULDER HUMERAL STEM W/O HEAD W/ BIOCOAT & W/ULTRACOAT - 14 MM

ENDOTEC, INC.

Total shoulder prosthesis

• Primary Device ID: 00814193025364
• NIH Device Record Key: e13ed181-49fb-43dd-89c6-16ecf7f673c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-P TOTAL SHOULDER SYSTEM
• Version Model Number: 02-04-0114
• Catalog Number: 02-04-0114
• 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

• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814193025364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904880

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