AccessGUDID - DEVICE: FMS (10886705030736)

GUDID

Device Identifier (DI) Information

Brand Name: FMS
Version or Model: 283712
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 283712
Company Name: Medos International Sàrl

Primary DI Number: 10886705030736
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: FMS Fluid Management System Tornado Micro II No-Button Shaver Handpiece Shaver handpiece without hand control

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?
36224	Arthroscopic shaver system, electrically-powered	A dedicated assembly of electrically-powered devices designed for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It typically consists of a power supply/control unit with operational display and dedicated software, intended to provide optimal parameters for the procedure, and a rotatory handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotatory instruments. An irrigation system may be included. Common procedures include cartilage debridement (e.g., meniscus repair or meniscectomy) and removal of the inflamed inner lining of the joint (synovectomy). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041824	000
K954465	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Waste from Electrical and Electronic Equipment

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e25fe455-5de6-437f-b03c-3270d709a119
Public Version Date: July 04, 2022
Public Version Number: 2
DI Record Publish Date: June 19, 2020