Wound GelHA TM

GUDID 00358407070011

WoundGelHA TM is indicated for the management of minor burns, abrasions, & cuts and helps relieve dry waxy skinassociated with dry skin conditions.

Industria Farmacéutica Andrómaco, S.A. de C.V.

Skin osmotic dressing, non-antimicrobial

• Primary Device ID: 00358407070011
• NIH Device Record Key: f230db6c-f9aa-41ed-80db-92e92b4e9455
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wound GelHA TM
• Version Model Number: One, 0.33 oz (9.45g) Tube
• Company DUNS: 810330282
• Company Name: Industria Farmacéutica Andrómaco, S.A. de C.V.
• 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: false
• 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	00358407070011 [Primary]

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-23
• Device Publish Date: 2022-05-13

Devices Manufactured by Industria Farmacéutica Andrómaco, S.A. de C.V.

• 00358407070011 - Wound GelHA TM: 2022-05-23WoundGelHA TM is indicated for the management of minor burns, abrasions, & cuts and helps relieve dry waxy skinassociated with dry skin conditions.
• 00358407070011 - Wound GelHA TM: 2022-05-23 WoundGelHA TM is indicated for the management of minor burns, abrasions, & cuts and helps relieve dry waxy skinassociated with d
• 00358407992511 - Wound GelHA Matrix: 2022-05-23 "WoundGelHA MatrixTM is formulated to provide wound care dressing and management. WoundGelHA MatrixTM is a combination of emolli
• 00358407992535 - Wound GelHA Matrix: 2022-05-23 "WoundGelHA MatrixTM is formulated to provide wound care dressing and management. WoundGelHA MatrixTM is a combination of emolli