MicroAire®

GUDID 00847399005878

Sterilization Case (plastic, pre-2018)

Microaire Surgical Instruments LLC

Surgical instrument/implant rack

• Primary Device ID: 00847399005878
• NIH Device Record Key: 145126e3-63cb-4f73-92bd-e3c8732110f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroAire®
• Version Model Number: 81040
• 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: true
• Serial Number: false
• 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	00847399005878 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032119

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-07
• Device Publish Date: 2018-08-07

On-Brand Devices [MicroAire®]

• 00847399015938: Handpiece
• 00847399015921: Sterilization Case (metal, 2018+)
• 00847399015877: LP Co-Equal
• 00847399015860: Low Profile (LP) Blade Assembly 6pk
• 00847399015853: Low Profile (LP) Blade Assembly 1pk
• 00847399015785: 1648-508NS2
• 00847399015778: 1624-509NS25
• 00847399015761: 1604-162NS25
• 00847399015754: 1603-162NS25
• 00847399015709: PAL-508LLB
• 00847399015693: PAL-408LLB
• 00847399015686: PAL-404LLB
• 00847399015679: PAL-304LLB
• 00847399015624: 201-05-00
• 00847399015617: 201-02-00
• 00847399008756: PAL-730
• 00847399008732: PAL-700
• 00847399008725: PAL-650
• 00847399008718: PAL-508LS
• 00847399008701: PAL-508LL
• 00847399008695: PAL-507LS
• 00847399008688: PAL-507LLT
• 00847399008671: PAL-507LL
• 00847399008664: PAL-506LS
• 00847399008657: PAL-506LL
• 00847399008640: PAL-505LS
• 00847399008633: PAL-505LLT
• 00847399008626: PAL-505LL
• 00847399008619: PAL-504LS
• 00847399008602: PAL-504LL
• 00847399008596: PAL-500
• 00847399008589: PAL-408LS
• 00847399008572: PAL-408LL
• 00847399008565: PAL-407LS
• 00847399008558: PAL-407LL
• 00847399008541: PAL-406LS
• 00847399008534: PAL-406LL
• 00847399008527: PAL-405LS
• 00847399008510: PAL-405LLT
• 00847399008503: PAL-405LL
• 00847399008497: PAL-404LST
• 00847399008480: PAL-404LS
• 00847399008473: PAL-404LLT
• 00847399008466: PAL-404LL
• 00847399008459: PAL-403LS
• 00847399008442: PAL-403LL
• 00847399008435: PAL-402LS
• 00847399008428: PAL-402LL
• 00847399008411: PAL-4012LL
• 00847399008404: PAL-4011LL