MENIETT®
GUDID 20885074415363
EARPLUG 1010021041 12PK RED 12.5MM
MEDTRONIC XOMED, INC.
Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use| Primary Device ID | 20885074415363 |
| NIH Device Record Key | 08a6499c-768e-4394-ac8f-3c9720d5cc7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MENIETT® |
| Version Model Number | 1010021041 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, 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
Device Dimensions
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
| Length | 12.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885074415369 [Primary] |
| GS1 | 20885074415363 [Package] Contains: 00885074415369 Package: PK [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K991562
FDA Product Code
| ETY | TESTER, AUDITORY IMPEDANCE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-03-04 |
| Device Publish Date | 2016-04-30 |
On-Brand Devices [MENIETT®]
| 00643169576476 | GENERATOR 1010020601LO MENIETT LOANER |
| 00643169344938 | GENERATOR 1010020601 MENIETT ROHS |
| 00721902935220 | DEVICE 1010020601 MENIETT GENERATOR |
| 00721902326271 | POWER SUPPLY 1010021008 MENIETT ROHS |
| 00721902326264 | CONNECTOR 1010021006 MENIETT EARPLUG |
| 00721902326257 | BATTERY 1010021005 MENIETT 9.6VDC ROHS |
| 20885074415400 | EARPLUG 1010021045 12PK CLEAR 19MM |
| 20885074415394 | EARPLUG 1010021044 12PK GREY 18MM |
| 20885074415387 | EARPLUG 1010021043 12PK BLUE 16MM |
| 20885074415370 | EARPLUG 1010021042 12PK GREEN 14MM |
| 20885074415363 | EARPLUG 1010021041 12PK RED 12.5MM |
| 20885074415356 | EARPLUG 1010021040 12PK GREY 11MM |
| 00885074138688 | GENERATOR 1010020601RF MENIETT REFURB |
Trademark Results [MENIETT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MENIETT 78100193 2882865 Live/Registered |
LINA MEDICAL APS 2001-12-28 |
 MENIETT 76318095 not registered Dead/Abandoned |
Pascal Medical AB 2001-09-27 |
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