AccessGUDID - DEVICE: CyclaPlex Drill Guide (07290017626192)

GUDID

Device Identifier (DI) Information

Brand Name: CyclaPlex Drill Guide
Version or Model: V7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DG-9201
Company Name: ALPHAMET LTD

Primary DI Number: 07290017626192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600372473 *Terms of Use

Device Description: The CyclaPlex Drill Guide is a “H arm” device intended to guide drill bits at the right points and required drilling angles in the 1st and 2nd metatarsal bones.

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:	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?
61929	Orthopaedic implant aiming/guiding block attachment tool	A manually-operated surgical instrument intended to be used to attach an orthopaedic implant aiming/guiding block to an implant (e.g., orthopaedic plate) to facilitate implantation. This is a reusable device.	Active	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: 8bfbc4d9-aaad-4abd-aa41-f35fe3ce857e
Public Version Date: February 20, 2020
Public Version Number: 1
DI Record Publish Date: February 12, 2020