AccessGUDID - DEVICE: StrykeFlow (07613327052060)

GUDID

Device Identifier (DI) Information

Brand Name: StrykeFlow
Version or Model: 0250070487
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0250-070-487
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327052060
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, Hydrodissection, Non-Reflective 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
Surgical/emergency suction cannula, non-illuminating, reusable	An atraumatic, invasive, hand-operated, single-lumen tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Surgical/emergency suction cannula, non-illuminating, reusable

An atraumatic, invasive, hand-operated, single-lumen tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. 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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Outer Diameter: 5.0 Millimeter
Length: 32.0 Centimeter

Device Record Status

Public Device Record Key: 09951833-9115-48e6-ab31-a6634e39512a
Public Version Date: February 21, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016