Iodoflex Dressing 5x5g USA 6602133005

GUDID 00040565122519

Cadexomer Iodine Pad

SMITH & NEPHEW MEDICAL LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 00040565122519
• NIH Device Record Key: 5922bb91-a49d-42e0-86f3-fdd0758dfb93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Iodoflex Dressing 5x5g USA
• Version Model Number: 6602133005
• Catalog Number: 6602133005
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00040565122502 [Primary]
GS1	00040565122519 [Package]; Contains: 00040565122502; Package: Carton [5 Units]; In Commercial Distribution
GS1	30040565122510 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190756

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-21
• Device Publish Date: 2020-09-18

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

• 05000223504151 - BIOBRANE: 2025-03-11 BIOBRANE DRESSING - SMALL GLOVE US
• 05000223504168 - BIOBRANE: 2025-03-11 BIOBRANE DRESSING - MEDIUM GLOVE US
• 05000223504175 - BIOBRANE: 2025-03-11 BIOBRANE DRESSING - LARGE GLOVE US
• 05000223504182 - BIOBRANE: 2025-03-11 BIOBRANE DRESSING - PEDIATRIC GLOVE US
• 05000223504113 - BIOBRANE: 2025-03-10 BIOBRANE DRESSING 5.1INX5.1IN CTN 5 US
• 05000223504137 - BIOBRANE: 2025-03-10 BIOBRANE DRESSING 9.8INX15IN CTN 1 US
• 05000223504144 - BIOBRANE: 2025-03-10 BIOBRANE DRESSING 15INX19.7IN CTN 1 US
• 05000223504120 - BIOBRANE: 2025-03-07 BIOBRANE DRESSING 5.1INX15IN CTN 5 (US)