AccessGUDID - DEVICE: Dynasty (00192629205550)

GUDID

Device Identifier (DI) Information

Brand Name: Dynasty
Version or Model: DLDMGE42
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DLDMGE42
Company Name: Microport Orthopedics Inc.

Primary DI Number: 00192629205550
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079118736 *Terms of Use

Device Description: Dynasty® Dual Mobility Liner Group E 42mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
48056	Metallic acetabular liner	An implantable inner component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of metal [e.g., cobalt-chrome (Co-Cr)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200011	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: 323e9f8e-7e79-4267-998f-7e8846441eb5
Public Version Date: October 15, 2021
Public Version Number: 1
DI Record Publish Date: October 07, 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
HIBCC	M684DLDMGE421

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(866)872-0211
Email: Stephen.Weaver@ortho.microport.com

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