PINNACLE RSS105
GUDID 50389701007453
PINNACLE Introducer Sheath
TERUMO MEDICAL CORPORATION
Vascular catheter introduction set, nonimplantable| Primary Device ID | 50389701007453 |
| NIH Device Record Key | 74c283b0-a2be-468c-ae02-586979791c1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PINNACLE |
| Version Model Number | RSS105 |
| Catalog Number | RSS105 |
| Company DUNS | 131489882 |
| Company Name | TERUMO MEDICAL CORPORATION |
| 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
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
| Catheter Gauge | 11 French |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 25 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00389701007458 [Primary] |
| GS1 | 30389701007459 [Package] Contains: 00389701007458 Package: Shelfbox [10 Units] In Commercial Distribution |
| GS1 | 50389701007453 [Package] Contains: 30389701007459 Package: Carton [10 Units] In Commercial Distribution |
FDA Product Code
| DYB | INTRODUCER, CATHETER |
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 | 2019-06-07 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [PINNACLE]
| 50389701009402 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 30389701009392 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 50389701009372 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 30389701009361 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 30389701009354 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 50389701009341 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 50389701009334 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 30389701009323 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 50389701009310 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 30389701009309 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 50389701009297 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 50389701009280 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 30389701009279 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 30389701009262 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 50389701009174 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 50389701009167 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 30389701009149 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 30389701009132 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 30389701009118 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 50389701009105 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
| 50389701008603 | PINNACLE TIF Introducer Sheath |
| 30389701008593 | PINNACLE TIF Introducer Sheath |
| 50389701008580 | PINNACLE TIF Introducer Sheath |
| 50389701008573 | PINNACLE TIF Introducer Sheath |
| 30389701008562 | PINNACLE TIF Introducer Sheath |
| 50389701008559 | PINNACLE TIF Introducer Sheath |
| 30389701008548 | PINNACLE TIF Introducer Sheath |
| 30389701008531 | PINNACLE TIF Introducer Sheath |
| 50389701008337 | PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker |
| 30389701008326 | PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker |
| 50389701008313 | PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker |
| 30389701008302 | PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker |
| 50389701008290 | PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker |
| 50389701008283 | PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker |
| 50389701007767 | PINNACLE Introducer Sheath |
| 50389701007750 | PINNACLE Introducer Sheath |
| 50389701007743 | PINNACLE Introducer Sheath |
| 30389701007732 | PINNACLE Introducer Sheath |
| 30389701007725 | PINNACLE Introducer Sheath |
| 30389701007718 | PINNACLE Introducer Sheath |
| 50389701007705 | PINNACLE Introducer Sheath |
| 50389701007699 | PINNACLE Introducer Sheath |
| 30389701007688 | PINNACLE Introducer Sheath |
| 50389701007675 | PINNACLE Introducer Sheath |
| 50389701007668 | PINNACLE Introducer Sheath |
| 30389701007657 | PINNACLE Introducer Sheath |
| 30389701007640 | PINNACLE Introducer Sheath |
| 50389701007637 | PINNACLE Introducer Sheath |
| 30389701007626 | PINNACLE Introducer Sheath |
| 50389701007613 | PINNACLE R/O II Introducer Sheath with Radiopaque Marker |
Trademark Results [PINNACLE]
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