AccessGUDID - DEVICE: NEBULAE SRS Laparoscopic Surgical Pump (00817183020684)

GUDID

Device Identifier (DI) Information

Brand Name: NEBULAE SRS Laparoscopic Surgical Pump
Version or Model: 7-700-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NORTHGATE TECHNOLOGIES INC.

Primary DI Number: 00817183020684
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627969264 *Terms of Use

Device Description: No description.

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):	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?
37861	Surgical plume evacuation system	A mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYD	Apparatus, Exhaust, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202944	000

Device Exempt from Premarket Submission: No 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: 09144469-2439-468f-a186-2a48a15d097b
Public Version Date: February 22, 2023
Public Version Number: 1
DI Record Publish Date: February 14, 2023