AccessGUDID - DEVICE: Crossfire (07613327058086)

GUDID

Device Identifier (DI) Information

Brand Name: Crossfire
Version or Model: 0475000000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0475000000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327058086
Issuing Agency: GS1
Commercial Distribution End Date: November 26, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: Console

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?
52529	Arthroscopic shaver/electrosurgical system generator	A mains electricity (AC-powered) device designed to provide energy for a system designed to perform arthroscopic shaving (i.e., abrasion, resection, debridement of bone and soft tissue with a blade) and electrosurgical diathermy (i.e., the ablation and coagulation of soft tissue, as well as haemostasis of blood vessels, with an electrosurgical probe) during arthroscopic procedures on a joint. The unit typically consists of an operational display, operator controls, and software to help provide optimal parameters for the connected shaver handpiece(s) and electrosurgical probe(s). It may include an irrigation system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	ARTHROSCOPE
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071859	000

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: f69a7f9f-52a0-4341-9eb3-0c4bec0e3626
Public Version Date: November 26, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2016