HOUSING CAP WITH O-RING 002 CAP W/O-RING

GUDID D785002CAPWO0

002 CAP WITH 002 BLK O-RING INSERTED

OCO BIOMEDICAL INC

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• Primary Device ID: D785002CAPWO0
• NIH Device Record Key: fe0b33c1-5eed-43cc-908f-066a24bfcae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOUSING CAP WITH O-RING
• Version Model Number: 002 CAP WITH 002 BLK O-RING INSERTED
• Catalog Number: 002 CAP W/O-RING
• 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	D785002CAPWO0 [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

• 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: 2024-03-20002 CAP WITH 002 BLK O-RING INSERTED
• D785002CAPWO0 - HOUSING CAP WITH O-RING: 2024-03-20 002 CAP WITH 002 BLK O-RING INSERTED
• D785002CAPWORED0 - HOUSING CAP WITH ORING RED: 2024-03-20 002 CAP WITH O-RING (RED)
• D785002CAPWORW0 - HOUSING CAP WITH ORING WHITE: 2024-03-20 002 CAP WITH O-RING (WHITE)
• D785003CAPWO0 - HOUSING CAP WITH BLK ORING: 2024-03-20 003 CAP WITH 003 BLK O-RING INSERTED