AccessGUDID - DEVICE: Aliform (08721325283047)

GUDID

Device Identifier (DI) Information

Brand Name: Aliform
Version or Model: CELL001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aliform B.V.

Primary DI Number: 08721325283047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 494548366 *Terms of Use

Device Description: Celluleaf - Surgical tool for subcutaneous blunt release of fibrous septae in soft tissues. The device is delivered sterile and intended for single use.

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:	Yes
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?
62558	General-purpose curette	A hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDI	Dissector, Surgical, General & Plastic Surgery

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Humidity: between 15 and 60 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b927876f-e47d-44a6-b4d1-8cceeaa3621f
Public Version Date: July 16, 2025
Public Version Number: 2
DI Record Publish Date: June 17, 2025