FDA UDI
In Commercial Distribution
🇺🇸 United States
USB Deluxe HV Heart Retractor Set
DI: 00850037179527
·
Model: HV-2025
·
USB Medical Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- USB Deluxe HV Heart Retractor Set
- Primary DI
- 00850037179527
- Version / Model
- HV-2025
- Catalog Number
- HV-2025
- Company Name
- USB Medical Limited
- Labeler DUNS
- 018543576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-07
- Public Version
- 1
- Public Version Date
- 2024-11-15
- Public Version Status
- New
- Public Device Record Key
- 0f2dc656-0ce9-40b2-aeaa-e985edbaad77
Device Description
Re-usable heart retractor for use in minimally invasive surgical procedures contains: HVR-H1 - Handle, HVR-X1 Hex Screwdriver, DF-101 Delivery Forceps, 6 each Mitral Blades, 2 each Tricuspid Blades, HVR-T2 Large Sterilization Tray
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45918 | Hand-held surgical retractor, reusable | A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850037179527 | GS1 |