SharkCore DSC-25-01
GUDID 00855208005094
Fine Needle Biopsy System
Covidien LP
General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use| Primary Device ID | 00855208005094 |
| NIH Device Record Key | 109d1ba6-d4d7-4ba2-afd5-e523bed7ff66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SharkCore |
| Version Model Number | DSC-25-01 |
| Catalog Number | DSC-25-01 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 | true |
| 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
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *; |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855208005094 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141894
FDA Product Code
| FCG | Biopsy needle |
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 | 2016-09-24 |
On-Brand Devices [SharkCore]
| 00855208005131 | Fine Needle Biopsy System |
| 00855208005124 | Fine Needle Biopsy Needle |
| 00855208005117 | Fine Needle Biopsy Needle |
| 00855208005100 | Fine Needle Biopsy Needle |
| 00855208005094 | Fine Needle Biopsy System |
| 00855208005087 | Fine Needle Biopsy System |
Trademark Results [SharkCore]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SHARKCORE 86295855 4697316 Live/Registered |
Covidien LP 2014-05-30 |
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