AccessGUDID - DEVICE: n.a. (04048551010501)

GUDID

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Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 7220BS
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551010501
Issuing Agency: GS1
Device Count: 1

Device Description: Suction and Irrigation Sheath 30°

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
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

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

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 Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 23, 2016
Commercial Distribution End Date:

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

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DEVICE: n.a. (04048551010501)