AccessGUDID - DEVICE: Bespoke (E314HPCCO0102010)

GUDID

Device Identifier (DI) Information

Brand Name: Bespoke
Version or Model: HPC-CO01-02-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HPC-CO01-02-01
Company Name: MATERIALISE USA, L.L.C.

Primary DI Number: E314HPCCO0102010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 946657160 *Terms of Use
Previous DI: E314HPCCO010201

Device Description: Consensus CT THA hip bone model

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:	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?
62249	Custom-made organ/bone anatomy model/surgical guide kit	A collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PLW	Acetabular Cup Orientation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150780	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: 7bdd3920-029b-4246-80eb-755be7c585cd
Public Version Date: November 27, 2019
Public Version Number: 4
DI Record Publish Date: July 21, 2017