ReyaGel

GUDID 08600103725002

ECM Wound Gel 3cc

STEMSYS LLC

Animal-derived wound matrix dressing

• Primary Device ID: 08600103725002
• NIH Device Record Key: 0b48a2cc-7cba-42cf-b31a-fa40e9307038
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReyaGel
• Version Model Number: RG03
• Company DUNS: 080053326
• Company Name: STEMSYS 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08600103725002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232204

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: 2026-02-10
• Device Publish Date: 2026-02-02

Devices Manufactured by STEMSYS LLC

• 08600103725002 - ReyaGel: 2026-02-10ECM Wound Gel 3cc
• 08600103725002 - ReyaGel: 2026-02-10 ECM Wound Gel 3cc
• 00864567000312 - XCelliStem: 2020-05-06 Wound Powder, 250mg
• 00864567000329 - XCelliStem: 2020-05-06 Wound Powder, 1000mg
• 00864567000336 - XCelliStem: 2020-05-06 Wound Powder, 500mg