AccessGUDID - DEVICE: Blueprint (03700434023114)

GUDID

Device Identifier (DI) Information

Brand Name: Blueprint
Version or Model: BPUE001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4.1.Win
Company Name: TORNIER

Primary DI Number: 03700434023114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 260324876 *Terms of Use

Device Description: WIN

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):	No
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?
41018	Orthopaedic CAD/CAM system	An assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (specifically prescribed to each patient's needs) orthopaedic implants typically involving the prescription forming (milling) of the femoral stem of a hip replacement for optimal fitting to that patient's bone anatomy. It typically includes three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for production of the prosthesis to be fitted to the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
QHE	Shoulder arthroplasty implantation system
PHX	shoulder prosthesis, reverse configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232265	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: ea8aefbe-a05b-4108-afd7-b3e6e08b0402
Public Version Date: March 22, 2024
Public Version Number: 1
DI Record Publish Date: March 14, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +330476613500
Email: order@tornier.com

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