Mammotome elite
GUDID 10841911100871
Introducer Stylet
DEVICOR MEDICAL PRODUCTS, INC.
Side-notch biopsy gun handpiece/needle| Primary Device ID | 10841911100871 |
| NIH Device Record Key | c8d833d3-fc33-415e-9b69-52f4fe9f5277 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mammotome elite |
| Version Model Number | MEI13 |
| Company DUNS | 961832156 |
| Company Name | DEVICOR MEDICAL PRODUCTS, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
| Needle Gauge | 13 Gauge |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841911100874 [Primary] |
| GS1 | 10841911100871 [Package] Contains: 00841911100874 Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153709
FDA Product Code
| KNW | Instrument, Biopsy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-14 |
| Device Publish Date | 2022-02-04 |
On-Brand Devices [Mammotome elite]
| 10841911100895 | Probe |
| 10841911100888 | Probe |
| 00841911100850 | Holster (tetherless vacuum-assisted biopsy system) |
| 10841911100871 | Introducer Stylet |
| 10841911100864 | Introducer Stylet |
| 00841911101703 | "Holster (tetherless vacuum-assisted biopsy system)" |
| 00841911102823 | Holster (tetherless vacuum-assisted biopsy system) |
| 10841911102806 | Probe |
| 10841911102790 | Mammotome Elite Probe |
Trademark Results [Mammotome elite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMOTOME ELITE 85782899 4364699 Live/Registered |
Devicor Medical Products, Inc. 2012-11-19 |
 MAMMOTOME ELITE 85320701 4203206 Live/Registered |
Devicor Medical Products, Inc. 2011-05-13 |
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