RegenKit Wound-Gel SE-RK-WG-1

GUDID 00850033131093

.

Regenlab USA LLC

Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive

• Primary Device ID: 00850033131093
• NIH Device Record Key: d94786a4-eb6f-4145-91ff-6a42065ea024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RegenKit Wound-Gel
• Version Model Number: RK-WG-1
• Catalog Number: SE-RK-WG-1
• Company DUNS: 087434117
• Company Name: Regenlab USA LLC
• 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: true
• 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	00850033131093 [Primary]

FDA Product Code

• PMQ: Peripheral Blood Processing Device For Wound Management

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: 2024-03-20
• Device Publish Date: 2024-03-12

Devices Manufactured by Regenlab USA LLC

• 00850033131093 - RegenKit Wound-Gel: 2024-03-20.
• 00850033131093 - RegenKit Wound-Gel: 2024-03-20 .
• 00850033131031 - RegenLab USA: 2023-05-08
• 00850033131048 - RegenLab USA: 2023-05-08
• 00850033131055 - RegenLab USA: 2023-05-08
• 00850033131062 - RegenLab USA: 2023-05-08
• 00850033131079 - RegenLab USA: 2023-05-08
• 00850033131086 - RegenLab USA: 2023-05-08
• 00850033131024 - Accessory Set: 2021-12-02