DORO LUNA® Retractor System
GUDID 04250435519349
DORO LUNA® Retractor System - Standard System consisting of: 1203.001 1203.002 1203.003 1203.004 1203.006 1203.091 1201.091 3
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable| Primary Device ID | 04250435519349 |
| NIH Device Record Key | 2c2acf14-4cda-430d-baca-b0d976e9f52e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DORO LUNA® Retractor System |
| Version Model Number | 1203.100 |
| Company DUNS | 313517922 |
| Company Name | pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250435519349 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K001808
FDA Product Code
| HBL | Holder, Head, Neurosurgical (Skull Clamp) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
[04250435519349]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2016-12-15 |
On-Brand Devices [DORO LUNA® Retractor System]
| 04250435519639 | DORO LUNA® Compact Retractor System & DORO® QR3 Headrest System consisting of: 3116-151 |
| 04250435519622 | DORO LUNA® Compact Retractor System & DORO® QR3 Skull Clamp consisting of: 3116-151 3116 |
| 04250435519615 | DORO LUNA® Standard Retractor System & DORO® QR3 Headrest System cons |
| 04250435519608 | DORO LUNA® Standard Retractor System & DORO® QR3 Skull Clamp consisting |
| 04250435519356 | DORO LUNA® Retractor System - Compact System consisting of: |
| 04250435519349 | DORO LUNA® Retractor System - Standard System consisting of: 1203.001 |
Trademark Results [DORO LUNA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DORO LUNA 79151056 4929538 Live/Registered |
pro med instruments GmbH Herstellung un 2014-06-27 |
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