AccessGUDID - DEVICE: N/A (00889024355835)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 20-8012-010-22
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-8012-010-22
Company Name: SYNVASIVE TECHNOLOGY, INC.

Primary DI Number: 00889024355835
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618258974 *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?
58989	Knee arthroplasty force sensor balance kit	A collection of non-sterile devices intended for use with a knee arthroplasty force sensor to measure forces acting across the joint to facilitate assessment of bone resection lines and size of prosthesis components to be implanted. It is intended to help achieve correct femoral rotation, flexion stability, proper patella tracking, and/or medial-lateral ligament balance. It typically consists of femoral components, tibial spacers, positioning guides, fixation screws, and an adjustment wrench. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

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: T-20

Device Record Status

Public Device Record Key: 51e53ed2-e398-4e7b-8fa2-37636cdca1a5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 07, 2016

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)348-2759
Email: zimmer.consumerrelations@zimmer.com

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