FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SIMPULSE
DI: 00801741065286
·
Model: 0057700
·
Davol Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SIMPULSE
- Primary DI
- 00801741065286
- Version / Model
- 0057700
- Catalog Number
- 0057700
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-23
- Public Version
- 6
- Public Version Date
- 2025-04-28
- Public Version Status
- Update
- Public Device Record Key
- 78768f22-d240-4347-81f9-9652443f2220
- Distribution End Date
- 2025-04-28
Device Description
Simpulse PLUS System with Ultrex Retractable Splash Shield Tip (1.75" diameter) Tip, Suction Tubing, and Dual Spike Adapter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 | 10801741065283 | GS1 | BX | 5 | Not in Commercial Distribution | 2025-04-28 |
| Primary | 00801741065286 | GS1 | ||||
| Package | 20801741065280 | GS1 | CA | 2 | Not in Commercial Distribution | 2025-04-28 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]