Calcium Alginate Dressing (10x10 in) GEN-13010

GUDID 00361554000954

Gentell, LLC

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

• Primary Device ID: 00361554000954
• NIH Device Record Key: 1b7f7734-2346-40c0-86a4-2ecb7c0a881b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calcium Alginate Dressing (10x10 in)
• Version Model Number: GEN-13010
• Catalog Number: GEN-13010
• Company DUNS: 170967876
• Company Name: Gentell, LLC
• Device Count: 10
• 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: true
• Manufacturing Date: true
• 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	00361554000930 [Unit of Use]
GS1	00361554000947 [Primary]
GS1	00361554000954 [Package]; Contains: 00361554000947; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• NAC: Dressing, Wound, Hydrophilic

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: 2025-02-24
• Device Publish Date: 2025-02-14

Devices Manufactured by Gentell, LLC

• 00361554000862 - Calcium Alginate Dressing (4x4 in): 2025-02-24
• 00361554000879 - Calcium Alginate Dressing (4x8 in): 2025-02-24
• 00361554000923 - Calcium Alginate Dressing (6x6 in): 2025-02-24
• 00361554000954 - Calcium Alginate Dressing (10x10 in): 2025-02-24
• 00361554000954 - Calcium Alginate Dressing (10x10 in): 2025-02-24
• 00361554002927 - Calcium Alginate Dressing (2x2 in): 2025-02-24
• 00361554005584 - Gentell: 2025-02-24 Hydrogel Sheet Dressing 2.4"x 2.4"
• 00361554005607 - Gentell: 2025-02-24 Hydrogel Sheet Dressing 7"x5"
• 00361554005621 - Gentell: 2025-02-24 Hydrogel Sheet Dressing 4.7"x3.4"