AccessGUDID - DEVICE: Patellar Component (EPIS61125PF0)

GUDID

Device Identifier (DI) Information

Brand Name: Patellar Component
Version or Model: D25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 61125PF
Company Name: Episurf Operations AB

Primary DI Number: EPIS61125PF0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 352393402 *Terms of Use

Device Description: No description.

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?
61841	Partial-resurfacing patella prosthesis	An implantable device designed to treat focal cartilage defects in the posterior surface of the patella by excision of the lesion and cemented fixation of the device in the surgically-prepared defect, with retention of the surrounding healthy articular cartilage. It typically consists of a disc-shaped device with a fixation stem, and is made of synthetic polymer [e.g., ultrahigh molecular weight polyethylene (UHMWPE)] mixed with a microbe-derived (biosynthetic) material [e.g., hyaluronic acid (HA)]. It is available in a range of sizes for treatment of different size lesions.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221048	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: a291e6e6-ef44-442f-94aa-2761997e4725
Public Version Date: August 01, 2023
Public Version Number: 1
DI Record Publish Date: July 24, 2023

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: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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