Millen
GUDID 00681490024785
PROSTHESIS 0564 MILLEN FLEX H/A OFF TOT
MEDTRONIC XOMED, INC.
Ossicular prosthesis, total| Primary Device ID | 00681490024785 |
| NIH Device Record Key | 5f69bda3-1038-4f3b-9a69-3c26aedafdc3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Millen |
| Version Model Number | 0564 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 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
Device Dimensions
| Length | 9 Millimeter |
| Length | 9 Millimeter |
| Length | 9 Millimeter |
| Length | 9 Millimeter |
| Length | 9 Millimeter |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681490024785 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K885201
FDA Product Code
| ETA | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
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 | 2018-07-06 |
| Device Publish Date | 2015-06-25 |
On-Brand Devices [Millen]
| 00681490024815 | PROSTHESIS 0568 MILLEN FLEX H/A OFF PART |
| 00681490024808 | PROSTHESIS 0567 MILLEN FLEX H/A OFF PART |
| 00681490024792 | PROSTHESIS 0565 MILLEN FLEX H/A OFF TOT |
| 00681490024785 | PROSTHESIS 0564 MILLEN FLEX H/A OFF TOT |
Trademark Results [Millen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MILLEN 73137906 1108591 Dead/Expired |
MILLEN INDUSTRIES, INC. 1977-08-17 |
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