B-P TOTAL KNEE SYSTEM 04-31-1301

GUDID 00814193020369

B-P KNEE NARROW FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, RIGHT, SIZE 1

ENDOTEC, INC.

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• Primary Device ID: 00814193020369
• NIH Device Record Key: ff2eff9a-d398-4dab-85aa-dd87ce587715
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-P TOTAL KNEE SYSTEM
• Version Model Number: 04-31-1301
• Catalog Number: 04-31-1301
• 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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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	00814193020369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012702

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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 KNEE SYSTEM]

• 00814193025586: B-P KNEE SUBLUXATION CONTROL SCREW W/ULTRACOAT SIZE 4-6
• 00814193025579: B-P KNEE SUBLUXATION CONTROL SCREW W/ULTRACOAT SIZE 1-3
• 00814193022431: B-P KNEE 3-PEG PATELLA COMPONENT, W/O BIOCOAT, W/ULTRACOAT, SIZE 6
• 00814193022424: B-P KNEE 3-PEG PATELLA COMPONENT, W/O BIOCOAT, W/ULTRACOAT, SIZE 5
• 00814193022417: B-P KNEE 3-PEG PATELLA COMPONENT, W/O BIOCOAT, W/ULTRACOAT, SIZE 4
• 00814193022400: B-P KNEE 3-PEG PATELLA COMPONENT, W/O BIOCOAT, W/ULTRACOAT, SIZE 3
• 00814193022394: B-P KNEE 3-PEG PATELLA COMPONENT, W/O BIOCOAT, W/ULTRACOAT, SIZE 2
• 00814193022387: B-P KNEE 3-PEG PATELLA COMPONENT, W/O BIOCOAT, W/ULTRACOAT, SIZE 1
• 00814193022370: B-P KNEE ALL POLY PATELLA COMPONENT SIZE 6
• 00814193022363: B-P KNEE ALL POLY PATELLA COMPONENT SIZE 5
• 00814193022356: B-P KNEE ALL POLY PATELLA COMPONENT SIZE 4
• 00814193022349: B-P KNEE ALL POLY PATELLA COMPONENT SIZE 3
• 00814193022332: B-P KNEE ALL POLY PATELLA COMPONENT SIZE 2
• 00814193022325: B-P KNEE ALL POLY PATELLA COMPONENT SIZE 1
• 00814193022318: B-P KNEE 3-PEG PATELLA COMPONENT, W/BIOCOAT, W/ULTRACOAT, SIZE 6
• 00814193022301: B-P KNEE 3-PEG PATELLA COMPONENT, W/BIOCOAT, W/ULTRACOAT, SIZE 5
• 00814193022295: B-P KNEE 3-PEG PATELLA COMPONENT, W/BIOCOAT, W/ULTRACOAT, SIZE 4
• 00814193022288: B-P KNEE 3-PEG PATELLA COMPONENT, W/BIOCOAT, W/ULTRACOAT, SIZE 3
• 00814193022271: B-P KNEE 3-PEG PATELLA COMPONENT, W/BIOCOAT, W/ULTRACOAT, SIZE 2
• 00814193022264: B-P KNEE 3-PEG PATELLA COMPONENT, W/BIOCOAT, W/ULTRACOAT, SIZE 1
• 00814193022257: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 6X10 MM
• 00814193022240: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 5X10 MM
• 00814193022233: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 4X10 MM
• 00814193022226: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 3X10 MM
• 00814193022219: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 2X10 MM
• 00814193022202: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 1X10 MM
• 00814193022196: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 6X7.5 MM
• 00814193022189: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 5X7.5 MM
• 00814193022172: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 4X7.5 MM
• 00814193022165: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 3X7.5 MM
• 00814193022158: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 2X7.5 MM
• 00814193022141: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 1X7.5 MM
• 00814193022134: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 6X5 MM
• 00814193022127: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 5X5 MM
• 00814193022110: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 4X5 MM
• 00814193022103: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 3X5 MM
• 00814193022097: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 2X5 MM
• 00814193022080: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 1X5 MM
• 00814193022073: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 6X2.5 MM
• 00814193022066: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 5X2.5 MM
• 00814193022059: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 4X2.5 MM
• 00814193022042: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 3X2.5 MM
• 00814193022035: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 2X2.5 MM
• 00814193022028: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 1X2.5 MM
• 00814193022011: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 6X0 MM
• 00814193022004: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 5X0 MM
• 00814193021991: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 4X0 MM
• 00814193021984: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 3X0 MM
• 00814193021977: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 2X0 MM
• 00814193021960: B-P KNEE PARTIALLY CONFORMING BEARING SIZE 1X0 MM