Gentell GEN-11470

GUDID 00361554005621

Hydrogel Sheet Dressing 4.7"x3.4"

Gentell, LLC

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00361554005621
• NIH Device Record Key: 9f71e8bc-e4b2-4c33-94fc-fb5b62b4f40e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gentell
• Version Model Number: GEN-11470
• Catalog Number: GEN-11470
• Company DUNS: 170967876
• Company Name: Gentell, LLC
• Device Count: 5
• 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: 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	00361554005621 [Unit of Use]
GS1	00361554005638 [Primary]

FDA Product Code

• NAE: Dressing, Wound, Hydrogel Without Drug And/Or Biologic

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

On-Brand Devices [Gentell]

• 00361554003184: Collagen Dressings 4"X4"
• 00361554003207: Collagen wound dressing, 7"x7"
• 00361554003153: Collagen wound dressing 2"x2"
• 00361554000787: Collagen Particles Wound Filler 1 gram Pouch
• 20361554000088: XXXXXX
• 10361554003051: XXX
• 10361554000135: Collagen wound dressings 7"x7"
• 10361554000081: XXXX
• 10361554002047: xxxx
• 00361554003863: Silicone Bordered gauze 8inx8in
• 00361554003856: Silicone Bordered Gauze 6inx6in
• 00361554003818: Silicone Bordered Gauze 4in x 4in
• 00361554003771: Honey Hydrogel Dressing 7in x5in
• 00361554003764: Honey Hydrogel Dressing 4.7in x3.4in
• 00361554003733: Honey Hydrogel Dressing 2.4in x2.4in
• 00361554005621: Hydrogel Sheet Dressing 4.7"x3.4"
• 00361554005607: Hydrogel Sheet Dressing 7"x5"
• 00361554005584: Hydrogel Sheet Dressing 2.4"x 2.4"