DEVICE: MicroAire® (00847399004680)

Device Identifier (DI) Information

MicroAire®
7100-111
In Commercial Distribution

Microaire Surgical Instruments LLC
00847399004680
GS1

1
103056420 *Terms of Use
SYNTHES(R) REAMER COUPLER
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58189 Bone/joint surgical power tool motorized handpiece/set, pneumatic
A pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a non-dental surgical procedure. It includes a pneumatic motor and one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

09173c41-9626-4925-88a8-525460841346
September 26, 2022
1
September 17, 2022
CLOSE

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
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE