AccessGUDID - DEVICE: OIC External Fixation System (10811998058570)

GUDID

Device Identifier (DI) Information

Brand Name: OIC External Fixation System
Version or Model: DR24-140C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ORTHOPAEDIC IMPLANT COMPANY, THE

Primary DI Number: 10811998058570
Issuing Agency: GS1
Commercial Distribution End Date: May 26, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 070061160 *Terms of Use

Device Description: 2.4MM X 140MM CALIBRATED STEP DRILL

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
43390	Fluted surgical drill bit, single-use	A 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, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.	Active	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 [?]
Premarket Submission Number Not Available/Not Released

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
Outer Diameter: 3.2 Millimeter
Length: 140 Millimeter

Device Record Status

Public Device Record Key: f41755d0-52da-4641-832b-a9585cbf996f
Public Version Date: September 29, 2021
Public Version Number: 2
DI Record Publish Date: May 26, 2021