AccessGUDID - DEVICE: SP MicroPen EVO Microneedling Cartridge (00850035498279)

GUDID

Device Identifier (DI) Information

Brand Name: SP MicroPen EVO Microneedling Cartridge
Version or Model: F5SP223
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bellus Medical, LLC

Primary DI Number: 00850035498279
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005677967 *Terms of Use

Device Description: MicroPen EVO Turbo Safety Cartridge (each). Cartridges are sterilized and packaged individually for single patient 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?
61222	Cosmetic micro-needling electronic handpiece cartridge, professional	A device intended to be fitted to an electronic cosmetic micro-needling handpiece for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It is a small, sealed cartridge containing micro-needles intended to be fitted to the distal tip of the handpiece; it does not include any injectable materials. It is intended to be used by a healthcare provider in a clinical setting. It is not intended to be used for energy-based skin treatment. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QAI	Powered Microneedle Device

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4fb72c7a-678a-4198-a500-185a38ffc9f5
Public Version Date: April 24, 2025
Public Version Number: 10
DI Record Publish Date: May 25, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10850035498290	12	00850035498293	In Commercial Distribution	Case
00850035498330	2	10850035498290	In Commercial Distribution	Case
00850035498293	1	00850035498279	In Commercial Distribution
00850035498835	2	10850035498290	In Commercial Distribution	Mixed Case
00850035498804	2	10850035498290	In Commercial Distribution	Mixed Case
00850035498323	1	10850035498290	In Commercial Distribution	Mixed Case
00850035498842	1	00850035498279	In Commercial Distribution	Mixed Case
00850035498859	1	00850035498279	In Commercial Distribution	Mixed Case
00850035498880	1	00850035498279	In Commercial Distribution	Each
00850035498897	1	10850035498290	In Commercial Distribution	Mixed Case
00850060751295	1	10850035498290	In Commercial Distribution	Mixed Case