Millen
GUDID 00681490024785
PROSTHESIS 0564 MILLEN FLEX H/A OFF TOT
MEDTRONIC XOMED, INC.
Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total 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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