FDA UDI
In Commercial Distribution
🇺🇸 United States
POWERPULSE
DI: 03596010421302
·
Model: 71277005
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- POWERPULSE
- Primary DI
- 03596010421302
- Version / Model
- 71277005
- Catalog Number
- 71277005
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-29
- Public Version
- 3
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 0d6171f9-1f25-4d28-ba2f-1270f6564362
Device Description
POWERPULSE LAVAGE HIP/KNEE DISPOSABLE UNIT WITHOUT SUCTION
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FQH | LAVAGE, JET | General Hospital | 880.5475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43667 | Surgical/orthopaedic lavage control unit | A mains electricity (AC-powered) device designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) by regulating a pulsatile jet of sterile fluid (typically saline). It is typically an electromechanical unit that includes a pump for irrigation/infusion of fluids, an extractor (frequently using vacuum), and controls for the rate of irrigation/infusion and withdrawal of the fluid; it usually operates with separate kits that include handpieces, tubing, and detachable tips (applicators) of various shapes and sizes for specific surgical applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 23596010421306 | GS1 | BX | 10 | In Commercial Distribution | |
| Primary | 03596010421302 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]