AccessGUDID - DEVICE: Doctor Nice (08964003163051)

GUDID

Device Identifier (DI) Information

Brand Name: Doctor Nice
Version or Model: 786-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: B. Ali Impex

Primary DI Number: 08964003163051
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645802117 *Terms of Use

Device Description: Reusable Trocar gastro-urology, complete set, 4.5mm, 1 cannula, 1 blunt, obturator Item number 786-03

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
63148	Pellet implantation cannula, single-use	A rigid tube intended for subcutaneous delivery of an implantable drug pellet. The cannula is typically designed with a proximal well/side-hole for pellet loading, and typically includes a trocar blade to assist cannula introduction and a push rod to drive the pellet down the cannula; the implant is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBQ	Trocar, Gastro-Urology

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

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: 0ce86127-9615-4f22-837e-2c1aa13dfbe4
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: November 09, 2023