AccessGUDID - DEVICE: Recedo Topical Gel (00381811000060)

GUDID

Device Identifier (DI) Information

Brand Name: Recedo Topical Gel
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Resilia Pharmaceuticals, Inc.

Primary DI Number: 00381811000060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117711487 *Terms of Use

Device Description: Recedo Topical Gel is an advanced formula scar gel intended for the management of old and new hypertrophic or keloid scarring resulting from burns, general surgical procedures, or trauma wounds.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44898	Scar-management dressing, reusable	A covering made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDA	Elastomer, Silicone, For Scar Management

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 20 Gram

Device Record Status

Public Device Record Key: 53040619-e2d7-4fad-84a8-6f7913b326a2
Public Version Date: June 20, 2024
Public Version Number: 1
DI Record Publish Date: June 12, 2024