FDA UDI
In Commercial Distribution
🇺🇸 United States
Simpulse SOLO
DI: 00801741010156
·
Model: 0067640
·
Davol Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Simpulse SOLO
- Primary DI
- 00801741010156
- Version / Model
- 0067640
- Catalog Number
- 0067640
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-23
- Public Version
- 4
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 71c7543d-f60b-41f9-9367-5e1747fb96eb
Device Description
The Simpulse SOLO System with Ultrex Retractable 1-1/4" Splash Shield Tip
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
- No
- 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 |
|---|---|---|---|---|
| 47890 | Disposable surgical irrigation/aspiration system | A device assembly 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) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741010153 | GS1 | BX | 5 | In Commercial Distribution | |
| Primary | 00801741010156 | GS1 | ||||
| Package | 20801741010150 | GS1 | CA | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 1.25 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 65 Percent (%) Relative Humidity