AccessGUDID - DEVICE: CyclaPlex Correction System Instruments Case (07290017626116)

GUDID

Device Identifier (DI) Information

Brand Name: CyclaPlex Correction System Instruments Case
Version or Model: V7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IC-9801
Company Name: ALPHAMET LTD

Primary DI Number: 07290017626116
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600372473 *Terms of Use

Device Description: The anodized aluminum Instruments Case is intended to accommodate the CyclaPlex surgery instruments in the right position for sterilization , surgery procedure and storage.

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?
13730	Device sterilization/disinfection container, reusable	A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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: 59a63480-2318-4de5-b0da-602e3d5014f3
Public Version Date: April 04, 2023
Public Version Number: 3
DI Record Publish Date: February 12, 2020