Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L
- Primary DI
- 00899054002821
- Brand
- Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L
- Company
- KDL MEDICAL, INC.
- Model
- HAF-2SHS
- Device description
- Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L
- Published
- 2025-02-10
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| DWS | Instruments, Surgical, Cardiovascular |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00899054002821 | Primary | GS1 | 0 | |
| 10899054002828 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00899054002821 | 00899054002821 | 899054002821 | 0899054002821 |
| 10899054002828 | 10899054002828 |
GMDN Terms#
| Term | Definition |
|---|---|
| Surgical instrument assist arm system, manually-adjusted | A manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base. |
Contacts#
| Phone | |
|---|---|
| 972-783-7005 | regulatory@chasemedical.com |
Regulatory Flags#
- DUNS number
- 791048924
- Device count
- 5
- Premarket exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00899054002067 | Mannequin™ Endoventricular Shaper | VRD-0080S | 2017-05-23 | |
| 00899054002098 | Mannequin™ Endoventricular Shaper | VRD-0090S | 2017-05-23 | |
| 00899054002111 | Mannequin™ Endoventricular Shaper | VRD-0100S | 2017-05-23 | |
| 00899054002142 | Mannequin™ Endoventricular Shaper | VRD-0110S | 2017-05-23 | |
| 00899054002166 | SVR System without Patch | SVC-0080S | 2017-05-23 | |
| 00899054002197 | Mannequin™ Endoventricular Shaper | VRD-0120S | 2017-05-23 | |
| 00899054002227 | Mannequin™ Endoventricular Shaper | VRD-0130S | 2017-05-23 | |
| 00899054002234 | Mannequin™ Endoventricular Shaper | VRD-0140S | 2017-05-23 | |
| 00899054002241 | Mannequin™ Endoventricular Shaper | VRD-0150S | 2017-05-23 | |
| 00899054002258 | Mannequin™ Endoventricular Shaper | VRD-0085S | 2017-05-23 | |
| 00899054002326 | SVR System without Patch | SVC-0085S | 2017-05-23 | |
| 00899054002333 | SVR System without Patch | SVC-0090S | 2017-05-23 | |
| 00899054002340 | SVR System without Patch | SVC-0100S | 2017-05-23 | |
| 00899054002357 | SVR System without Patch | SVC-0110S | 2017-05-23 | |
| 00899054002364 | SVR System without Patch | SVC-0120S | 2017-05-23 | |
| 00899054002371 | SVR System without Patch | SVC-0130S | 2017-05-23 | |
| 00899054002388 | SVR System without Patch | SVC-0140S | 2017-05-23 | |
| 00899054002395 | SVR System without Patch | SVC-0150S | 2017-05-23 | |
| 00899054002838 | Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L | HAF-2LGS | 2025-02-10 | |
| 00899054002845 | Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm L | HAF-3SHS | 2025-02-10 |
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