AccessGUDID - DEVICE: ACHIEVECAS (00885556074176)

GUDID

Device Identifier (DI) Information

Brand Name: ACHIEVECAS
Version or Model: 74453001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 74453001
Company Name: Smith & Nephew, Inc.

Primary DI Number: 00885556074176
Issuing Agency: GS1
Commercial Distribution End Date: March 17, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: ACHIEVECAS FEMORAL GUIDE ADJUSTABLE RIGHT

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?
45200	Orthopaedic stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAW	Neurological stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012938	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: 50f58a39-807f-4bbd-a910-7e49c463c3bd
Public Version Date: September 07, 2023
Public Version Number: 6
DI Record Publish Date: September 28, 2015