OptiSeal™
GUDID 10821329600590
Valved Peelable PTFE Introducer
Greatbatch Ltd
Vascular catheter introduction set, nonimplantable| Primary Device ID | 10821329600590 |
| NIH Device Record Key | 98c31f62-c857-4e4f-8ec4-62059755a4ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiSeal™ |
| Version Model Number | 1000093-007 |
| Company DUNS | 968623467 |
| Company Name | Greatbatch Ltd |
| 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 | true |
| 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 |
Device Dimensions
| Length | 13 Centimeter |
| Length | 13 Centimeter |
| Length | 13 Centimeter |
| Length | 13 Centimeter |
| Length | 13 Centimeter |
| Length | 13 Centimeter |
| Length | 13 Centimeter |
| Length | 13 Centimeter |
| Length | 13 Centimeter |
| Length | 13 Centimeter |
| Length | 13 Centimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Lumen/Inner Diameter | 4.2 Millimeter |
| Length | 13 Centimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821329600593 [Primary] |
| GS1 | 10821329600590 [Package] Contains: 00821329600593 Package: BOX [5 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 | 2 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2018-09-24 |
On-Brand Devices [OptiSeal™]
| 10821329601481 | Valved Peelable PTFE Introducer |
| 10821329601474 | Valved Peelable PTFE Introducer |
| 10821329601467 | Valved Peelable PTFE Introducer |
| 10821329601450 | Valved Peelable PTFE Introducer |
| 10821329601443 | Valved Peelable PTFE Introducer |
| 10821329601436 | Valved Peelable PTFE Introducer |
| 10821329601429 | Valved Peelable PTFE Introducer |
| 10821329601412 | Valved Peelable PTFE Introducer |
| 10821329601405 | Valved Peelable PTFE Introducer |
| 10821329601399 | Valved Peelable PTFE Introducer |
| 10821329601382 | Valved Peelable PTFE Introducer |
| 10821329601375 | Valved Peelable PTFE Introducer |
| 10821329601368 | Valved Peelable PTFE Introducer |
| 10821329601351 | Valved Peelable PTFE Introducer |
| 10821329600934 | Valved PTFE Peelable Introducer |
| 10821329600927 | Valved PTFE Peelable Introducer |
| 10821329600910 | Valved PTFE Peelable Introducer |
| 10821329600903 | Valved PTFE Peelable Introducer |
| 10821329600897 | Valved PTFE Peelable Introducer |
| 10821329600880 | Valved PTFE Peelable Introducer |
| 10821329600873 | Valved PTFE Peelable Introducer |
| 10821329600866 | Valved PTFE Peelable Introducer |
| 10821329600859 | Valved PTFE Peelable Introducer |
| 10821329600842 | Valved PTFE Peelable Introducer |
| 10821329600835 | Valved PTFE Peelable Introducer |
| 10821329600828 | Valved PTFE Peelable Introducer |
| 10821329600811 | Valved PTFE Peelable Introducer |
| 10821329600804 | Valved PTFE Peelable Introducer |
| 10821329600798 | Valved PTFE Peelable Introducer |
| 10821329600781 | Valved PTFE Peelable Introducer |
| 10821329600774 | Valved PTFE Peelable Introducer |
| 10821329600767 | Valved PTFE Peelable Introducer |
| 10821329600750 | Valved PTFE Peelable Introducer |
| 10821329600743 | Valved PTFE Peelable Introducer |
| 10821329600736 | Valved PTFE Peelable Introducer |
| 10821329600729 | Valved PTFE Peelable Introducer |
| 10821329600712 | Valved PTFE Peelable Introducer |
| 10821329600699 | Valved PTFE Peelable Introducer |
| 10821329600682 | Valved PTFE Peelable Introducer |
| 10821329600675 | Valved PTFE Peelable Introducer |
| 10821329600668 | Valved PTFE Peelable Introducer |
| 10821329600651 | Valved Peelable PTFE Introducer |
| 10821329600644 | 1000093-013 |
| 10821329600637 | Valved Peelable PTFE Introducer |
| 10821329600620 | Valved Peelable PTFE Introducer |
| 10821329600613 | Valved Peelable PTFE Introducer |
| 10821329600606 | Valved Peelable PTFE Introducer |
| 10821329600590 | Valved Peelable PTFE Introducer |
| 10821329600583 | Valved Peelable PTFE Introducer |
| 10821329600576 | Valved Peelable PTFE Introducer |
Trademark Results [OptiSeal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTISEAL 87209221 not registered Dead/Abandoned |
Olympus Corporation 2016-10-19 |
 OPTISEAL 79353910 not registered Live/Pending |
FISHER & PAYKEL HEALTHCARE LIMITED 2022-08-01 |
 OPTISEAL 78041490 2507256 Live/Registered |
MERCK KGAA 2001-01-03 |
 OPTISEAL 77709392 3897749 Live/Registered |
GREATBATCH LTD. 2009-04-08 |
 OPTISEAL 77022805 3631883 Live/Registered |
BERRY PLASTICS CORPORATION 2006-10-17 |
 OPTISEAL 76121385 2651169 Dead/Cancelled |
Sensitisers International, Ltd. 2000-09-05 |
 OPTISEAL 75217641 not registered Dead/Abandoned |
Univier International Corporation 1996-12-23 |
 OPTISEAL 75108335 not registered Dead/Abandoned |
Sensitisers International, Ltd. 1996-05-23 |
 OPTISEAL 74348436 1851953 Live/Registered |
J. H. FENNER & CO. LIMITED 1993-01-14 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.