AccessGUDID - DEVICE: Metha® (04046963183721)

GUDID

Device Identifier (DI) Information

Brand Name: Metha®
Version or Model: NC079K
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NC079K
Company Name: Aesculap AG

Primary DI Number: 04046963183721
Issuing Agency: GS1
Commercial Distribution End Date: November 17, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: METHA NECK 12/14 130°/7.5°L RETRO-R ANTE

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?
59688	Femoral head/stem prosthesis adaptor	A sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented

FDA Premarket Submission

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

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
Device Size Text, specify: Taper Size : 12/14
Device Size Text, specify: CCD angle (°) : 130 / 7.5

Device Record Status

Public Device Record Key: c93adebb-9c66-49be-848d-11431d97d0d6
Public Version Date: April 23, 2021
Public Version Number: 3
DI Record Publish Date: July 27, 2015

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

[?]

Phone: +1(888)229-3002
Email: setworld_orders@aesculap.com

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