Dynarex Corporation

GUDID 36970754494866

GCMEDICA ENTERPRISE LTD. (WUXI)

Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner

• Primary Device ID: 36970754494866
• NIH Device Record Key: f83323a0-510d-4fbc-ade4-82516457e88b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynarex Corporation
• Version Model Number: GC1957R08
• Company DUNS: 527142751
• Company Name: GCMEDICA ENTERPRISE LTD. (WUXI)
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16970754494862 [Primary]
GS1	36970754494866 [Package]; Contains: 16970754494862; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• GCX: Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-13
• Device Publish Date: 2023-02-04

Devices Manufactured by GCMEDICA ENTERPRISE LTD. (WUXI)

• 16970754496156 - Orthopaedic Suction Set: 2023-09-18 Sterile, single use, easyflow filtered suction system, for orthopaedic surgery.
• 36970754494866 - Dynarex Corporation: 2023-02-13
• 36970754494866 - Dynarex Corporation: 2023-02-13