AccessGUDID - DEVICE: Encompass™ SRS Fibreplast™ System (10841962109519)

GUDID

Device Identifier (DI) Information

Brand Name: Encompass™ SRS Fibreplast™ System
Version or Model: RT-B889KYCF2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RT-B889KYCF2
Company Name: Qfix

Primary DI Number: 10841962109519
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808875397 *Terms of Use

Device Description: Encompass Fibreplast Variable Perf Open View Mask System

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
40896	Patient positioning thermoplastic mould material	A thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heating in hot water and while softened, are moulded around the patient's anatomy. When cooled, it hardens to form a custom-made mould or cast of that part of the body. After the moulding process is complete, it is typically attached to a board, frame, or another patient positioning system (PPS) or immobilization device. After application, this device cannot be reused (i.e., remoulded).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPS	System, tomography, computed, emission
OUO	Tomographic imager combining emission computed tomography with nuclear magnetic resonance
JAI	Couch, radiation therapy, powered
JAK	System, x-ray, tomography, computed
LHN	System, radiation therapy, charged-particle, medical
LNH	System, nuclear magnetic resonance imaging
IYE	Accelerator, linear, medical

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: 7f589607-2d15-4ef6-bab3-e5921b350ea6
Public Version Date: December 11, 2023
Public Version Number: 5
DI Record Publish Date: September 14, 2016