AccessGUDID - DEVICE: MicroAire® (00847399017246)

GUDID

Device Identifier (DI) Information

Brand Name: MicroAire®
Version or Model: 83030-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 83030-6
Company Name: Microaire Surgical Instruments LLC

Primary DI Number: 00847399017246
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
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: f38ef4d9-c6ec-4e8a-a0f1-d55188a68f44
Public Version Date: June 23, 2022
Public Version Number: 1
DI Record Publish Date: June 15, 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
10847399017243	6	00847399017246		In Commercial Distribution	PK

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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