FDA UDI
In Commercial Distribution
🇺🇸 United States
OptiSeal™
DI: 00821329600616
·
Model: 1000092-013
·
Greatbatch Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OptiSeal™
- Primary DI
- 00821329600616
- Version / Model
- 1000092-013
- Company Name
- Greatbatch Ltd
- Labeler DUNS
- 968623467
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-26
- Public Version
- 2
- Public Version Date
- 2019-06-07
- Public Version Status
- Update
- Public Device Record Key
- efacf1da-5d6d-4ec5-8b31-d34a3d99f2e3
Device Description
Valved Peelable PTFE Introducer
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10821329600613 | GS1 | BOX | 5 | In Commercial Distribution | |
| Primary | 00821329600616 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 12 | Milliliter | |
| Needle Gauge | 18 | Gauge | |
| Length | 60 | Centimeter | |
| Outer Diameter | .89 | Millimeter | |
| Length | 25 | Centimeter | |
| Lumen/Inner Diameter | 3.8 | Millimeter | |
| Catheter Gauge | 11 | French |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 40 Degrees Celsius