AccessGUDID - DEVICE: Surgical Direct (B382SD50003S0)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Direct
Version or Model: SD500-03s
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SD500-03s
Company Name: Surgical Direct, Inc.

Primary DI Number: B382SD50003S0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124367223 *Terms of Use

Device Description: Latex Free 10 ft Insufflation tubing, 22mm Direct Connector w .1 Micron Filter Sterile one time use, 1

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:	Yes
Prescription Use (Rx):	No
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?
38559	Insufflation gas conditioning tubing set	A collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKC	Tubing/tubing with filter, insufflation, laparoscopic

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: 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: 0990043b-ed95-439b-b95a-a1c93fcb4681
Public Version Date: April 17, 2024
Public Version Number: 2
DI Record Publish Date: November 30, 2022