AccessGUDID - DEVICE: Abeon Remora XL Smoke and Fluid Evacuation System (00842071109929)

GUDID

Device Identifier (DI) Information

Brand Name: Abeon Remora XL Smoke and Fluid Evacuation System
Version or Model: ST9020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071109929
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: Smoke and Fluid Evacuation System XL (Box 10)

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):	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?
48027	Surgical fluid/smoke waste management system suction unit	A mobile, mains electricity (AC-powered) device assembly designed to collect surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a suction pump, tubing, collection containers, a vacuum gauge, a vacuum control knob, an overflow trap, and a special filter for smoke evacuation. It uses negative pressure (suction) at the site of intervention to collect fluid in its collection containers and filter captured smoke with its filters. It is attached to a dedicated disposal unit for automatic container emptying and cleaning to prepare for the next use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971758	000

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: ecf90ec1-c50b-481a-8e85-c66e5a7041ec
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016