Zyston® Strut 104M3311
GUDID 00880304864542
BIOMET SPINE LLC
Surgical tamp, reusable| Primary Device ID | 00880304864542 |
| NIH Device Record Key | aee78efe-04e4-46ec-ab26-a58db969f986 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zyston® Strut |
| Version Model Number | 104M3311 |
| Catalog Number | 104M3311 |
| Company DUNS | 018577570 |
| Company Name | BIOMET SPINE LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304864542 [Primary] |
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2018-07-13 |
On-Brand Devices [Zyston® Strut]
Trademark Results [Zyston]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZYSTON 77945862 4039201 Live/Registered |
ZIMMER BIOMET SPINE, INC. 2010-02-26 |
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