AccessGUDID - DEVICE: OIC External Fixation System (10811998038343)

GUDID

Device Identifier (DI) Information

Brand Name: OIC External Fixation System
Version or Model: DR40-200C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORTHOPAEDIC IMPLANT COMPANY, THE

Primary DI Number: 10811998038343
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070061160 *Terms of Use

Device Description: 4.0MM X 200MM CALIBRATED DRILL BIT

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?
47563	Fluted surgical drill bit, single-use, non-sterile	A non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171211	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
Length: 200 Millimeter
Outer Diameter: 4.0 Millimeter

Device Record Status

Public Device Record Key: e19438d6-4ffc-423d-b70e-f3a604dda0be
Public Version Date: November 22, 2018
Public Version Number: 2
DI Record Publish Date: July 31, 2018