AccessGUDID - DEVICE: ERBE (04050147015692)

GUDID

Device Identifier (DI) Information

Brand Name: ERBE
Version or Model: 10135-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10135-000
Company Name: Erbe Elektromedizin GmbH

Primary DI Number: 04050147015692
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316116623 *Terms of Use

Device Description: Erbe APC 3 Argon Plasma Coagulation Unit

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?
36154	Argon-enhanced electrosurgical system gas delivery unit	A device designed to deliver argon (Ar) gas from an Ar gas source to an argon-enhanced electrosurgical system. It is typically incorporated into a trolley (cart) and is connected to the electrosurgical diathermy generator, enabling a single control for the system. The argon gas is delivered through an appropriate handpiece and active electrode (not included) to minimize tissue charring and enhance coagulation at and around the site of operation.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191234	000

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
Storage Environment Temperature: between -29 and 60 Degrees Celsius
Handling Environment Temperature: between -29 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
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: 263b8f8a-2986-4454-962e-863de2f91e0d
Public Version Date: March 02, 2021
Public Version Number: 2
DI Record Publish Date: January 22, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4970717550
Email: info@erbe-med.com

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