AccessGUDID - DEVICE: n.a. (04048551048382)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 10390LN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551048382
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: Coagulation Suction Tube, 55 mm

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
Basic suction tip, reusable	A device that is attached to a suction system via the distal end of a suction tube and used for the rapid removal of bulk matter (e.g., vomit, mucus, tissue debris) from a natural or surgical cavity. It is a general-purpose suction tip and will typically be designed with a finger hole in its handle portion which is used by the operator to control the level of suction applied during the procedure or treatment. It is typically made of plastic or metal materials. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Basic suction tip, reusable

A device that is attached to a suction system via the distal end of a suction tube and used for the rapid removal of bulk matter (e.g., vomit, mucus, tissue debris) from a natural or surgical cavity. It is a general-purpose suction tip and will typically be designed with a finger hole in its handle portion which is used by the operator to control the level of suction applied during the procedure or treatment. It is typically made of plastic or metal materials. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
EOB	NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K944797	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
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e9b1a518-d34c-460b-ac55-5ac7d2f1cf41
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016