AccessGUDID - DEVICE: HYBRID(TM) GLENOID (00880304456334)

GUDID

Device Identifier (DI) Information

Brand Name: HYBRID(TM) GLENOID
Version or Model: 406113
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 406113
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304456334
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *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:	No
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?
58748	Pure wool pillow	A device made of pure new wool, typically sheep's wool, intended to support the head, especially during rest and sleep, to help relieve medical ailments such as pain, muscle tension, poor blood circulation, and to provide comfort by improving overall mobility and warmth. It is available in various shapes and sizes. It is typically used for rheumatologic treatment after injury, inflammation of tendons, muscles, degenerative changes and pain syndrome in joints and spine, arthritic symptoms, migraine pain and neuralgia. It consists of a case with at least one side made of 100% wool filled with various materials (e.g., polyester fabric, memory foam, latex foam). This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
HWT	TEMPLATE

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 4MM HYBRID(TM) GLENOID TRIAL, MEDIUM

Device Record Status

Public Device Record Key: ed5ea0e3-032b-4e1d-885a-a35be7b4bc94
Public Version Date: May 30, 2025
Public Version Number: 6
DI Record Publish Date: March 20, 2017

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

Customer Contact

[?]

Phone: +1(800)348-9500
Email: customerservice@zimmerbiomet.com

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