AccessGUDID - DEVICE: MicroAire® (00847399003850)

GUDID

Device Identifier (DI) Information

Brand Name: MicroAire®
Version or Model: 5401
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Microaire Surgical Instruments LLC

Primary DI Number: 00847399003850
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103056420 *Terms of Use

Device Description: FOOT PEDAL

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?
58029	Foot-switch, pneumatic	A gas-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g. a pneumatic surgical saw, pneumatic wire driver, pneumatic surgical power tool system control unit) to which it is connected typically via one or more hoses and which is dependent upon pressurized gas [e.g., medical air, nitrogen (N2)]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And 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 -20 and 60 Degrees Celsius
Handling Environment Atmospheric Pressure: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e66ae3ab-a3d9-4ab7-915e-be0ce60bdbd6
Public Version Date: February 15, 2022
Public Version Number: 1
DI Record Publish Date: February 07, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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