AccessGUDID - DEVICE: NA (00085412001029)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 2C4030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2C4030
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412001029
Issuing Agency: GS1
Commercial Distribution End Date: September 18, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: Two Lead Arthroscopic Irrigation Set

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):	Yes
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46102	Surgical irrigation tubing set, single-use	A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	ARTHROSCOPE
LJH	System, irrigation, urological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960787	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7fa7a06d-0bca-4e5a-9692-fbded45c9788
Public Version Date: December 19, 2024
Public Version Number: 8
DI Record Publish Date: September 24, 2016