AccessGUDID - DEVICE: ERBE (04050147000698)

GUDID

Device Identifier (DI) Information

Brand Name: ERBE
Version or Model: 20132-059
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20132-059
Company Name: Erbe Elektromedizin GmbH

Primary DI Number: 04050147000698
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316116623 *Terms of Use

Device Description: APC membrane filter, 0.2 µm

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:	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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Argon-enhanced electrosurgical system filter	A sterile device intended to prevent fluids and bacterial contaminants from entering an argon-enhanced electrosurgical system generator during surgical procedures. It is a meshed piece placed between the generator and the connected handpiece/electrode. This is a single-use device.

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K024047	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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from heat and direct sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8061d2f5-3ade-4314-bb33-fdbdd702aa18
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 16, 2017