B-P TOTAL SHOULDER SYSTEM 02-03-0048

GUDID 00814193025302

B-P SHOULDER HUMERAL RESURFACING HEAD W/BIOCOAT & W/ULTRACOAT - 48 MM

ENDOTEC, INC.

Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis

• Primary Device ID: 00814193025302
• NIH Device Record Key: 77ce67e6-3153-42cb-a1dd-0f7287c8b8dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-P TOTAL SHOULDER SYSTEM
• Version Model Number: 02-03-0048
• Catalog Number: 02-03-0048
• 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: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 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	00814193025302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992394

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

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