AccessGUDID - DEVICE: DISPOSABLE HYDROPHOBIC HEPA FILTER FOR CABINET SUCTION LINE

GUDID

Device Identifier (DI) Information

Brand Name: DISPOSABLE HYDROPHOBIC HEPA FILTER FOR CABINET SUCTION LINE - 24 PACK
Version or Model: S 850020-24
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GLOBAL SURGICAL CORPORATION

Primary DI Number: 00810040253195
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 824793335 *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?
44380	ENT cabinet	A stand-alone, furniture-like device designed to store, display, and provide readily accessible for the operator the instruments, devices, and materials, including the local anaesthetics used in ear/nose/throat (ENT) treatments/procedures. This device is used in hospitals and physician's offices and will typically have a worktop intended to facilitate the intervention. The device may include features, e.g., suction and pressure pumps, fibreoptic-light source, built-in electrical outlets. It will have wheels for easy movement.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETF	Unit, Examining/Treatment, Ent

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: b3dcb918-e1b6-4cd2-9157-6dc5ee9cb106
Public Version Date: January 12, 2024
Public Version Number: 2
DI Record Publish Date: September 20, 2021