AccessGUDID - DEVICE: ERBE (04050147000605)

GUDID

Device Identifier (DI) Information

Brand Name: ERBE
Version or Model: 20132-044
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20132-044
Company Name: Erbe Elektromedizin GmbH

Primary DI Number: 04050147000605
Issuing Agency: GS1
Commercial Distribution End Date: August 30, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 316116623 *Terms of Use

Device Description: APC-Applicator, rigid, OD: 5mm L: 100mm w/adjust. 14mm needle

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?
61879	Inert gas-enhanced open-surgery electrosurgical electrode, reusable	A rigid, invasive, distal component of an inert gas-enhanced electrosurgical system intended to be connected to a handpiece (not included) to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation during open surgery. It is typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery sleeve; it requires a patient contact return electrode to complete the circuit. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003462	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: Keep away from heat and direct sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Length: 100.000 Millimeter

Device Record Status

Public Device Record Key: 865ed12c-fd96-47f5-a3cf-504067608713
Public Version Date: April 04, 2023
Public Version Number: 4
DI Record Publish Date: September 13, 2016