AccessGUDID - DEVICE: VerSys® (00889024135871)

GUDID

Device Identifier (DI) Information

Brand Name: VerSys®
Version or Model: 7833-11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-7833-011-00
Company Name: Zimmer, Inc.

Primary DI Number: 00889024135871
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?
34223	Uncoated hip femur prosthesis, one-piece	A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is one-piece and is not coated with materials intended to improve fixation and stability. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
KWL	Prosthesis, hip, hemi-, femoral, metal
JDG	Prosthesis, hip, femoral component, cemented, metal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K955473	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
Device Size Text, specify: 12/14 Neck Taper, Size 11, 120 mm Stem Length

Device Record Status

Public Device Record Key: f15fa0a1-6b18-40ed-bbdb-7506a9b0c257
Public Version Date: June 08, 2020
Public Version Number: 4
DI Record Publish Date: September 17, 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(800)348-2759
Email: zimmer.consumerrelations@zimmerbiomet.com

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