PINNACLE PRECISION ACCESS SYSTEM 70-4165
GUDID 30389701010862
PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath
TERUMO MEDICAL CORPORATION
Vascular catheter introduction set, nonimplantable| Primary Device ID | 30389701010862 |
| NIH Device Record Key | c6255ca9-68f0-47d9-b10a-78095abefb17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PINNACLE PRECISION ACCESS SYSTEM |
| Version Model Number | 70-4165 |
| Catalog Number | 70-4165 |
| 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
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
| Length | 10 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 4 French |
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 | 00389701010861 [Primary] |
| GS1 | 30389701010862 [Package] Contains: 00389701010861 Package: Shelfbox [10 Units] In Commercial Distribution |
| GS1 | 50389701010866 [Package] 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 PRECISION ACCESS SYSTEM]
| 30389701010886 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 30389701010862 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 30389701010800 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 30389701010794 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 50389701010781 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 50389701010774 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 30389701010763 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 30389701010701 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 50389701010668 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 50389701010507 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 30389701010497 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 50389701010484 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 30389701010473 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
| 50389701010460 | PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath |
Trademark Results [PINNACLE PRECISION ACCESS SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PINNACLE PRECISION ACCESS SYSTEM 85368042 4276564 Live/Registered |
Terumo Kabushiki Kaisha (Terumo Corporation) 2011-07-11 |
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