MicroAire®

GUDID 00847399016027

SmartRelease Handpiece

Microaire Surgical Instruments LLC

Endoscopic soft-tissue release system handpiece

• Primary Device ID: 00847399016027
• NIH Device Record Key: 64d523ba-df53-4736-b61c-008f83190be0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroAire®
• Version Model Number: 85014
• Company DUNS: 103056420
• Company Name: Microaire Surgical Instruments LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847399016027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211297

FDA Product Code

• HRX: Arthroscope

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00847399016027]

Moist Heat or Steam Sterilization

[00847399016027]

Moist Heat or Steam Sterilization

[00847399016027]

Moist Heat or Steam Sterilization

[00847399016027]

Moist Heat or Steam Sterilization

[00847399016027]

Moist Heat or Steam Sterilization

[00847399016027]

Moist Heat or Steam Sterilization

[00847399016027]

Moist Heat or Steam Sterilization

[00847399016027]

Moist Heat or Steam Sterilization

[00847399016027]

Moist Heat or Steam Sterilization

[00847399016027]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-02
• Device Publish Date: 2021-10-25

On-Brand Devices [MicroAire® ]

• 00847399006899: CFD-899-4000
• 00847399006837: CFD-19001
• 00847399004109: 5740-600
• 00847399004093: 5740-200
• 00847399004086: 5740-100
• 00847399004062: 5740-062S
• 00847399004055: 5740-062
• 00847399004048: 5740-061S
• 00847399004031: 5740-061
• 00847399004024: 5740-060
• 00847399004017: 5740-020S
• 00847399004000: 5740-020
• 00847399003997: 5740-010S
• 00847399003980: 5740-009S
• 00847399003973: 5740-009
• 00847399003966: 5740-008
• 00847399003959: 5740-006S
• 00847399003942: 5740-006
• 00847399003935: 5740-005S
• 00847399003928: 5740-005
• 00847399003911: 5740-004S
• 00847399003904: 5740-004
• 00847399003768: 4740-013
• 00847399003751: 4700-016
• 00847399003744: 4700-015
• 00847399015785: 1648-508NS2
• 00847399015778: 1624-509NS25
• 00847399015761: 1604-162NS25
• 00847399015754: 1603-162NS25
• 00847399006776: Endotine Midface B Screw Clipper
• 00847399006752: Endotine Midface B Instrument Kit
• 00847399006721: Endotine Midface B Tap Tool
• 00847399006691: Endotine Forehead Instrument Kit
• 00847399006677: Endotine Forehead Insertion Tool
• 00847399006646: CAP-600E
• 00847399005830: 81025A
• 00847399005823: 81025
• 00847399003195: 1648-709TNS
• 00847399003188: 1648-709T
• 00847399003171: 1648-709NS
• 00847399003164: 1648-709
• 00847399003157: 1648-609TNS
• 00847399003140: 1648-609T
• 00847399003133: 1648-609NS
• 00847399003126: 1648-609
• 00847399003119: 1648-509TNS
• 00847399003102: 1648-509T
• 00847399003096: 1648-509NS
• 00847399003089: 1648-509
• 00847399003072: 1648-109TNS