AccessGUDID - DEVICE: StrykeFlow (07613327051773)

GUDID

Device Identifier (DI) Information

Brand Name: StrykeFlow
Version or Model: 0250070408
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0250-070-408
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327051773
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: Reusable Suction Irrigation Tip, Standard, Vented, Metal Finish

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
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K934094	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

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Size Type Text
Length: 45.0 Centimeter
Outer Diameter: 5.0 Millimeter

Device Record Status

Public Device Record Key: ce27447d-afed-4233-898c-1445f2011af0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016