HOUSING CAP WITH WHITE O-RING 003 CAP W/O-RING (WHITE)

GUDID D785003CAPWOW0

003 CAP WITH 003 WHT O-RING INSERTED

OCO BIOMEDICAL INC

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• Primary Device ID: D785003CAPWOW0
• NIH Device Record Key: b225ff2c-d023-4125-a87c-2150f7dd4f81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOUSING CAP WITH WHITE O-RING
• Version Model Number: 003 CAP WITH 003 WHT O-RING INSERTED
• Catalog Number: 003 CAP W/O-RING (WHITE)
• Company DUNS: 094146123
• Company Name: OCO BIOMEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D785003CAPWOW0 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-20
• Device Publish Date: 2024-03-12

Devices Manufactured by OCO BIOMEDICAL INC

• D785AS3100TSI0 - TSI/ERI Abutment Screw: 2024-05-07 TSI/ERI Abutment Screw 3.25mm
• D785AS4100TSI0 - TSI/ERI Abutment Screw: 2024-05-07 TSI/ERI Abutment Screw 4.0/5.0mm
• D78529SDIOBPK0 - 2.9 SDI O-BALL PROSTHETIC KIT: 2024-04-29 2.9MM SDI O-BALL PROSTHETIC KIT
• D78540TPKOB0 - TSI PROSTHETIC KIT: 2024-04-25 4.0MM TWO-STAGE O-BALL PROSTHETIC KIT
• D785325ICBPK0 - ISI C&B PROSTHETIC KIT: 2024-04-17 3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT
• D785002ORKIT0 - O-RING PACK: 2024-04-11 002 O-Ring Kit
• D785003ORKIT0 - O-RING PACK: 2024-04-11 003 O-Ring Kit
• D785002CAPWO0 - HOUSING CAP WITH O-RING: 2024-03-20 002 CAP WITH 002 BLK O-RING INSERTED