AccessGUDID - DEVICE: CARDINAL HEALTH (10197106106907)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: PBV2OTN12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PBV2OTN12
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10197106106907
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: KIT,GYN GU ROBOTICS

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:	Yes
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?
44092	Laparoscopic surgical procedure kit, medicated	A collection of various sterile surgical and endoscopic instruments (e.g., trocars, sleeves, cannulae), dressings, pharmaceuticals, and the necessary materials used to perform a laparoscopic surgical procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHD	Gynecological laparoscopic kit

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f0f2c5ee-6192-4d02-bc7a-8eaf8ec18528
Public Version Date: February 14, 2023
Public Version Number: 1
DI Record Publish Date: February 06, 2023