AccessGUDID - DEVICE: n.a. (04048551098547)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 28162XA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551098547
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: Clamp screw

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
Neurological endoscope holder	A device intended to be used to hold and fix in position a rigid or flexible endoscope during a diagnostic or therapeutic neurological procedure. It is typically made of high-grade stainless steel and anodized aluminium and will usually be affixed to the operating/examination table enabling the surgeon to freely use both hands. 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 [?]
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: 4e3ad47b-67f0-40d2-8142-7973d9d0d245
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016