B-P TOTAL HIP SYSTEM 01-04-0116

GUDID 00814193023193

B-P HIP FEMORAL STEM W/O HEAD, W/ BIOCOAT & ULTRACOAT - 16 MM

ENDOTEC, INC.

Ceramic-on-polyethylene total hip prosthesis

• Primary Device ID: 00814193023193
• NIH Device Record Key: a5d50480-6de7-41ff-ba23-e898cb9419cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-P TOTAL HIP SYSTEM
• Version Model Number: 01-04-0116
• Catalog Number: 01-04-0116
• 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

• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 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
• 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	00814193023193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884789

FDA Product Code

• KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

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 HIP SYSTEM ]

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