AccessGUDID - DEVICE: L2L® (00889024581968)

GUDID

Device Identifier (DI) Information

Brand Name: L2L®
Version or Model: 00-8700-001-24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-8700-001-24
Company Name: Zimmer, Inc.

Primary DI Number: 00889024581968
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056038268 *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?
33701	Elbow radius prosthesis	A sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWI	PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

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
Height: 12.00 Millimeter
Device Size Text, specify: 24 mm Diameter

Device Record Status

Public Device Record Key: 84d980bd-b994-4e2f-b6d9-af559bb044e9
Public Version Date: October 29, 2019
Public Version Number: 1
DI Record Publish Date: October 21, 2019

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(800)348-2759
Email: zimmer.consumerrelations@zimmerbiomet.com

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