GLOBAL UNITE™ Short Stem Instrumentation
GUDID 00817766026423
SHORT HUMERAL CASE
SYMMETRY MEDICAL INC.
Device sterilization/disinfection container, reusable| Primary Device ID | 00817766026423 |
| NIH Device Record Key | 0534fdcf-a16b-4628-a639-20c2b9a85fd2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GLOBAL UNITE™ Short Stem Instrumentation |
| Version Model Number | 223600211 |
| Company DUNS | 079881212 |
| Company Name | SYMMETRY MEDICAL 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 | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817766026423 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K012105
FDA Product Code
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
[00817766026423]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-04-04 |
| Device Publish Date | 2021-09-01 |
On-Brand Devices [GLOBAL UNITE™ Short Stem Instrumentation]
| 00817766026423 | SHORT HUMERAL CASE |
| 00847538018776 | SHORT BULLET TIP REAMER 16MM |
| 00847538018769 | SHORT BULLET TIP REAMER 14MM |
| 00847538018745 | SHORT BULLET TIP REAMER 12MM |
| 00847538018738 | SHORT BULLET TIP REAMER 10MM |
| 00847538018721 | SHORT BULLET TIP REAMER 8MM |
Trademark Results [GLOBAL UNITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GLOBAL UNITE 85031209 4183731 Live/Registered |
DePuy Synthes, Inc. 2010-05-05 |
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