Arcpoint ILS-2100-PN
GUDID 20884521809502
Pulmonary Needle
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 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 | 20884521809502 |
| NIH Device Record Key | 837da40e-314f-43f6-96d9-3c5eca9602f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arcpoint |
| Version Model Number | ILS-2100-PN |
| Catalog Number | ILS-2100-PN |
| 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 | true |
| 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 | |
| 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
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
| Needle Gauge | 21 Gauge |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521809505 [Primary] |
| GS1 | 20884521809502 [Package] Contains: 10884521809505 Package: CASE [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163537
FDA Product Code
| EOQ | Bronchoscope (flexible or rigid) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-23 |
| Device Publish Date | 2020-10-15 |
On-Brand Devices [Arcpoint]
| 20884521723624 | pulmonary needle |
| 20884521723617 | pulmonary needle |
| 20884521809502 | Pulmonary Needle |
| 20884521809496 | Pulmonary Needle |
Trademark Results [Arcpoint]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARCPOINT 87244535 5397578 Live/Registered |
Reason LLC 2016-11-21 |
 ARCPOINT 87235747 5481911 Live/Registered |
Covidien LP 2016-11-14 |
 ARCPOINT 77848619 3881304 Live/Registered |
ARCPOINT HOLDINGS, LLC 2009-10-14 |
 ARCPOINT 75340070 2780937 Dead/Cancelled |
NTT COMMUNICATIONS KABUSHIKI KAISHA 1997-08-13 |
 ARCPOINT 75340069 2570506 Dead/Cancelled |
NTT COMMUNICATIONS KABUSHIKI KAISHA 1997-08-13 |
 ARCPOINT 75340068 2593336 Dead/Cancelled |
NTT COMMUNICATIONS KABUSHIKI KAISHA 1997-08-13 |
 ARCPOINT 75340067 2472611 Dead/Cancelled |
NTT COMMUNICATIONS KABUSHIKI KAISHA 1997-08-13 |
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