AccessGUDID - DEVICE: The OR Company-InsufflatOR Needle (04711605991643)

GUDID

Device Identifier (DI) Information

Brand Name: The OR Company-InsufflatOR Needle
Version or Model: IN-12-4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADVANCED MEDICAL DESIGN CO., LTD.

Primary DI Number: 04711605991643
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656305567 *Terms of Use

Device Description: Insufflation needle 12cm

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?
12750	Spring-loaded pneumoperitoneum needle, single-use	A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIF	Insufflator, Laparoscopic

FDA Premarket Submission

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

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
Length: 120 Millimeter

Device Record Status

Public Device Record Key: c333cf6d-6cf2-45da-bc96-609327781cf5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016