AccessGUDID - DEVICE: Aura (00841747186707)

GUDID

Device Identifier (DI) Information

Brand Name: Aura
Version or Model: APKA 150
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COLLEGE PARK INDUSTRIES, INC.

Primary DI Number: 00841747186707
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623191137 *Terms of Use

Device Description: Aura Polycentric Knee Assembly

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?
64719	Hydraulic/pneumatic external knee prosthesis	A device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for motion control is based on hydraulics and/or pneumatics (e.g., using fixed fluid orifices, or needle or servo valves). It responds to changes in motion by providing variable damping through progressive adjustments [i.e. over several steps] in motion resistance. It may have various designs and functional features (e.g., monocentric or polycentric, manual lock, stance flexion) for support during a variety of activities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISY	Joint, Knee, External Limb Component

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 0e5b7401-9566-4cbb-b92d-b519fb0ca3ef
Public Version Date: June 27, 2024
Public Version Number: 1
DI Record Publish Date: June 19, 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: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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