AccessGUDID - DEVICE: MicroAire® (00847399004505)

GUDID

Device Identifier (DI) Information

Brand Name: MicroAire®
Version or Model: 7000-020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Microaire Surgical Instruments LLC

Primary DI Number: 00847399004505
Issuing Agency: GS1
Commercial Distribution End Date: December 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 103056420 *Terms of Use

Device Description: PNEUMATIC AIR HOSE, MICROAIRE CONNECTOR

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?
37869	Pneumatic surgical power tool hose	A single- or double-lumen (coaxial) tube in a straight or spiral design intended to be used to conduct compressed surgical-grade air or nitrogen (N2) gas from a gas source, usually the central medical gas supply system, to a surgical drilling system or sawing system handpiece or motor to supply it with power. The device is usually from 2 to 5 meters in length and is commonly designed according to ISO5359. The coaxial types have a double tube (inner and outer tubing) to facilitate the removal of the exhaust gases. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -18 and 49 Degrees Celsius
Handling Environment Atmospheric Pressure: between 0 and 91 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 6 Meter

Device Record Status

Public Device Record Key: 7b792e9f-db9e-4926-9147-c0a85bf86796
Public Version Date: July 04, 2022
Public Version Number: 3
DI Record Publish Date: December 29, 2021