AccessGUDID - DEVICE: AHTO (07613327061475)

GUDID

Device Identifier (DI) Information

Brand Name: AHTO
Version or Model: 0250070640
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 250-070-640
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327061475
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: Disposable Suction/Irrigator Tube Set, Dual Spike

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:	Yes
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 tubing set	A collection of sterile, flexible, noninvasive, double-lumen tubing intended to provide twin conduits in a surgical irrigation/aspiration system, to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical field through one lumen, and provide aspiration (suction) through the other lumen (i.e., capable of both functions), during a surgical procedure (e.g., dental, laparoscopy). It may include associated items (e.g., clamps, valves, filters, spikes and connectors), and a manual pump for channelling between the irrigation source and the point of application. Some types may have additional tubing to assist gastric lavage. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Surgical irrigation/aspiration tubing set

A collection of sterile, flexible, noninvasive, double-lumen tubing intended to provide twin conduits in a surgical irrigation/aspiration system, to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical field through one lumen, and provide aspiration (suction) through the other lumen (i.e., capable of both functions), during a surgical procedure (e.g., dental, laparoscopy). It may include associated items (e.g., clamps, valves, filters, spikes and connectors), and a manual pump for channelling between the irrigation source and the point of application. Some types may have additional tubing to assist gastric lavage. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
KQT	EVACUATOR, GASTRO-UROLOGY
GCX	APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042454	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: aa993ebe-39e7-4bae-bd64-fd9a3b9c6ffb
Public Version Date: February 07, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016