AccessGUDID - DEVICE: Regard™ (10326053115247)

GUDID

Device Identifier (DI) Information

Brand Name: Regard™
Version or Model: GS1027
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Primary DI Number: 10326053115247
Issuing Agency: GS1
Commercial Distribution End Date: August 26, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 945020902 *Terms of Use

Device Description: ROBOT GYN MERCY ST ANTHONY

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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?
44096	Laparoscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, 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 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6cbbf17b-fc46-497f-af08-928c3de39f9f
Public Version Date: August 27, 2020
Public Version Number: 2
DI Record Publish Date: April 23, 2018