Super Absorbent Dressing 6" x 6" GEN-19360

GUDID 10361554005420

Gentell, LLC

Wound-nonadherent dressing, absorbent, non-antimicrobial

• Primary Device ID: 10361554005420
• NIH Device Record Key: 15aeae5a-53dd-40c0-bd5d-7fc24ca522f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Super Absorbent Dressing 6" x 6"
• Version Model Number: GEN-19360
• Catalog Number: GEN-19360
• 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	00361554005416 [Unit of Use]
GS1	00361554005423 [Primary]
GS1	10361554005420 [Package]; Contains: 00361554005423; 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: 2025-02-28
• Device Publish Date: 2025-02-20

Devices Manufactured by Gentell, LLC

• 00361554007229 - Gentell: 2025-09-03 GEN13022 Gelling Fiber Ag Dressing 2”x2” (5cmx5cm)
• 00361554007250 - Gentell: 2025-09-03 GEN13044 Gelling Fiber Ag Dressing 4”x4” (10cmx10cm)
• 00361554007182 - Gentell: 2025-09-03 GEN13066 Gelling Fiber Ag Dressing 6”x6” (15cmx15cm)
• 00361554003375 - Gentell: 2025-08-29 GEN13020 Gelling Fiber Dressing 2”x2” (5cmx5cm)
• 00361554001098 - Gentell: 2025-08-29 GEN13040 Gelling Fiber Dressing 4”x4” (10cmx10cm)
• 00361554001128 - Gentell: 2025-08-29 GEN13060 Gelling Fiber Dressing 6”x6” (15cmx15cm)
• 15056860000072 - Gentell Hydrogel Sheet Dressing: 2025-08-29 GEN-11470 Gentell Hydrogel Sheet Dressing, 120mm x 86mm (4.7” x 3.4”), Borderless
• 15056860000089 - Gentell Hydrogel Sheet Dressing: 2025-08-29 GEN-11700 Gentell Hydrogel Sheet Dressing, 178mm x 127mm (7” x 5”), Borderless