Alliance™ SBGL8000
GUDID 00889024574892
Zimmer, Inc.
Orthopaedic implant aiming/guiding block, reusable| Primary Device ID | 00889024574892 |
| NIH Device Record Key | f6e51a21-2b1b-413b-bb3a-f0409de5c50e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alliance™ |
| Version Model Number | SBGL8000 |
| Catalog Number | SBGL8000 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, Inc. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024574892 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191814
FDA Product Code
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024574892]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-28 |
| Device Publish Date | 2019-11-20 |
On-Brand Devices [Alliance™]
Trademark Results [Alliance]
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