AccessGUDID - DEVICE: AMSure® Irrigation Tray with Bulb Syringe (10704411008101)

GUDID

Device Identifier (DI) Information

Brand Name: AMSure® Irrigation Tray with Bulb Syringe
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS130
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411008101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: AMSure® Irrigation Tray with Bulb Syringe CONTENTS: 1 each 1000 cc Outer Tray 1 each 500 cc Graduated Container 1 each 60 cc Bulb Irrigation Syringe 1 each Tip Protector 1 each Alcohol Prep Pad 1 each Large Moisture-Proof Underpad

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":	Yes
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32043	Laparoscopic surgical procedure kit, non-medicated, reusable	A collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYZ	Syringe, Irrigating (Non Dental)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5a83f6a9-c8d2-4b6a-bfdb-4fdfaa122c8e
Public Version Date: November 30, 2018
Public Version Number: 3
DI Record Publish Date: May 30, 2018