Tensure
- Primary DI
- M95580020
- Brand
- Tensure
- Company
- SENTREHEART, INC
- Model
- 7 lb
- Catalog number
- 8002
- Device description
- A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature loop in situ (e.g., during vascular surgery). The ligature is intended to be loaded into the device, which typically includes a sliding mechanism, allowing controlled manual tightening; the device may also include tightening markers. This is a single-use device
- Published
- 2018-09-17
- Public version status
- Update
- 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 |
|---|---|
| MDM | Instrument, Manual, Surgical, General Use |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| M95580020 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Ligature loop tightener | A hand-held manual surgical instrument intended for controlled tightening of a ligature/suture loop in situ during open and/or minimally-invasive surgery (e.g., during vascular surgery). The suture is intended to be loaded into the device, which typically includes a sliding mechanism or a rigid tube with an internal wire loop, allowing controlled manual tightening; the device may also include tightening markers. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 650-354-1200 | info@sentreheart.com |
Regulatory Flags#
- DUNS number
- 068810802
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
Other Devices Sharing Product Codes#
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|---|---|---|---|---|
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| 00190776427641 | Millennium | Avalign Technologies, Inc. | MDM | 2026-08-26 |
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| 00850088713626 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-08-25 |
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