AccessGUDID - DEVICE: CyclaPlex Drill Bits 1.8-3.0 (07290017626161)

GUDID

Device Identifier (DI) Information

Brand Name: CyclaPlex Drill Bits 1.8-3.0
Version or Model: V7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DB-9243
Company Name: ALPHAMET LTD

Primary DI Number: 07290017626161
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600372473 *Terms of Use

Device Description: The 1.8 and 3.0 mm quick coupling drill bits are intended to be used for implantation of CyclaPlex Implant.

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":	Yes
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?
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
HTN	Washer, Bolt Nut

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183094	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: 5b461d3b-0e89-45c0-a223-52a469bae101
Public Version Date: May 19, 2020
Public Version Number: 2
DI Record Publish Date: February 12, 2020