AccessGUDID - DEVICE: ERBE (04050147000629)

GUDID

Device Identifier (DI) Information

Brand Name: ERBE
Version or Model: 20132-046
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20132-046
Company Name: Erbe Elektromedizin GmbH

Primary DI Number: 04050147000629
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316116623 *Terms of Use

Device Description: Connect. cable for APC applic. APC 2; APC 300; L 2.5 m

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

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

GMDN Preferred Term Name	GMDN Definition
Argon-enhanced electrosurgical cable	An noninvasive, flexible, electrical cord with and integrated gas tube intended to be used as part of an argon-enhanced electrosurgical system to enable both electrical connection and argon gas supply from the system generator/gas delivery unit to the handpiece/electrode. It does not include a handpiece. This is a reusable device.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963189	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

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Storage and Handling
Special Storage Condition, Specify: Keep away from heat and direct sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

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Size Type Text
Length: 2.500 Meter

Device Record Status

Public Device Record Key: 8b54cbfb-6f14-4295-a575-daefd47eb330
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 13, 2016