AccessGUDID - DEVICE: Opus Colibri 1mm Single-use Tip (X1) (17290110122185)

GUDID

Device Identifier (DI) Information

Brand Name: Opus Colibri 1mm Single-use Tip (X1)
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AACL03052002
Company Name: ALMA LASERS LTD.

Primary DI Number: 17290110122185
Issuing Agency: GS1
Commercial Distribution End Date: November 14, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 532283264 *Terms of Use

Device Description: Opus Colibri 1mm Single-use Tip one unit

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
45219	Radio-frequency skin contouring system	An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
NUV	Massager, Vacuum, Light Induced Heating
ISA	Massager, Therapeutic, Electric
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

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: No
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: 7c14bcd6-f26b-4521-8bc9-6c0430797810
Public Version Date: October 02, 2024
Public Version Number: 2
DI Record Publish Date: November 14, 2021