Destino Reach Steerable Guiding Sheath
- Primary DI
- 00885672007232
- Brand
- Destino Reach Steerable Guiding Sheath
- Company
- Oscor Inc.
- Model
- DCR0857722
- Catalog number
- DCR0857722
- Device description
- Steerable Guiding Sheath, 8.5F
- Published
- 2017-11-27
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
oscor.comProduct Codes#
| Code | Name |
|---|---|
| DYB | INTRODUCER, CATHETER |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K151951 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00885672007232 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00885672007232 | 00885672007232 | 885672007232 | 0885672007232 |
GMDN Terms#
| Term | Definition |
|---|---|
| Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Lumen/Inner Diameter | 0 |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 0 | 0 |
Contacts#
| Phone | |
|---|---|
| +1(727)937-2511 | sales@oscor.com |
Regulatory Flags#
- DUNS number
- 101835833
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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