AccessGUDID - DEVICE: MicroAire® (00847399016010)

GUDID

Device Identifier (DI) Information

Brand Name: MicroAire®
Version or Model: 85050-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 85050-6
Company Name: Microaire Surgical Instruments LLC

Primary DI Number: 00847399016010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103056420 *Terms of Use

Device Description: Onyx Blade Assembly, SmartRelease

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):	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?
65788	Endoscopic soft-tissue release system blade	A patient-contact cutting component of an endoscopic soft-tissue release system intended to be used for minimally- invasive transection of soft connective tissue (e.g., fascia, tendon) under direct vision. It consists of a blade within a fenestrated tube that is connected to a dedicated handpiece (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope
EMF	Knife, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211297	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: d437601e-4535-4d1c-8b15-cec4bbe76339
Public Version Date: November 02, 2021
Public Version Number: 1
DI Record Publish Date: October 25, 2021