Gentell GEN-18000

GUDID 00361554000787

Collagen Particles Wound Filler 1 gram Pouch

Gentell, LLC

Collagen wound matrix dressing

• Primary Device ID: 00361554000787
• NIH Device Record Key: 07682d05-0d71-4d82-bd5e-bb0083d606ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gentell
• Version Model Number: GEN-18000
• Catalog Number: GEN-18000
• Company DUNS: 170967876
• Company Name: Gentell, LLC
• Device Count: 5
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00361554000770 [Unit of Use]
GS1	00361554000787 [Primary]
GS1	00361554000794 [Package]; Package: case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232796

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

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: 2024-07-10
• Device Publish Date: 2024-07-02

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