AccessGUDID - DEVICE: MicroAire® (00847399006776)

GUDID

Device Identifier (DI) Information

Brand Name: MicroAire®
Version or Model: CFD-020-4400
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Microaire Surgical Instruments LLC

Primary DI Number: 00847399006776
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 103056420 *Terms of Use

Device Description: Endotine Midface B Screw Clipper

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:	No
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?
32885	Wire cutter	A heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041835	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 7f6c52b1-8771-49bd-b406-5b4ac0fe4673
Public Version Date: July 07, 2023
Public Version Number: 4
DI Record Publish Date: August 17, 2016