AccessGUDID - DEVICE: n.a. (04048551103739)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 28164CBK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551103739
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: Irrigation Sheath

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

GMDN Preferred Term Name	GMDN Definition
Surgical irrigation/aspiration handpiece, reusable	A hand-held device designed to regulate and direct a stream of pressurized, warmed fluid (e.g., sterile water or saline) and alternatively provide aspiration (suction) to a surgical site for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Surgical irrigation/aspiration handpiece, reusable

A hand-held device designed to regulate and direct a stream of pressurized, warmed fluid (e.g., sterile water or saline) and alternatively provide aspiration (suction) to a surgical site for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
GWG	ENDOSCOPE, NEUROLOGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982837	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bbf3aebd-9124-4bc7-ad32-4a47ac39ba59
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016