AccessGUDID - DEVICE: DJO SURGICAL (00190446673231)

GUDID

Device Identifier (DI) Information

Brand Name: DJO SURGICAL
Version or Model: 952-28-50I
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Encore Medical, L.P.

Primary DI Number: 00190446673231
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154074504 *Terms of Use

Device Description: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD50

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":	Yes
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?
65063	Bipolar femoral head outer component, total arthroplasty	An implantable hemisphere-shaped device used as part of a total hip arthroplasty (THA) and designed to interface with the acetabular liner on its outer surface where it freely rotates, and encompass/interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head; it is not a femoral head prosthesis. It is a one-piece device made of polyethylene (PE).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203557	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: 0448a9e4-6a36-4dbb-8681-2330f12337d0
Public Version Date: June 28, 2022
Public Version Number: 2
DI Record Publish Date: May 12, 2021

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

Customer Contact

[?]

No Customer Contact currently defined

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