AccessGUDID - DEVICE: ERBE (04050147019737)

GUDID

Device Identifier (DI) Information

Brand Name: ERBE
Version or Model: 10448-004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10448-004
Company Name: Erbe Elektromedizin GmbH

Primary DI Number: 04050147019737
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316116623 *Terms of Use

Device Description: ERBOCRYO® CA Cryosurgical System, 120 V/60Hz, UL

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
General cryosurgical system, cryogen gas, mechanical	An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

GMDN Preferred Term Name

GMDN Definition

General cryosurgical system, cryogen gas, mechanical

An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

FDA Product Code

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Product Code	Product Code Name
GEH	UNIT, CRYOSURGICAL, ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051509	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

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Storage and Handling
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from heat and direct sunlight

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b7e34c05-b174-4520-98a3-c5e7eead25c7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 10, 2016