XCelliStem

GUDID 00864567000336

Wound Powder, 500mg

STEMSYS LLC

Collagen wound matrix dressing

• Primary Device ID: 00864567000336
• NIH Device Record Key: ad7a335c-06d0-4e3a-b123-22ba5a18477a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XCelliStem
• Version Model Number: XSWP0500
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864567000336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172593

FDA Product Code

• KGN: Dressing, Wound, Collagen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-08-15

On-Brand Devices [XCelliStem]

• 00864567000336: Wound Powder, 500mg
• 00864567000329: Wound Powder, 1000mg
• 00864567000312: Wound Powder, 250mg