Identity
- Trade Name
- SIMPULSE FDA UDI
- Generic Name
- Surgical irrigation/aspiration pump, single-use FDA UDI
- Device Name
- VariCare Retractable Splash Shield Wound Tip FDA UDI
- Model / Reference
- 0067320 FDA UDI
- Description
- VariCare Retractable Splash Shield Wound Tip FDA UDI
Identifiers
- Catalog Number
- 0067320 FDA UDI
- Primary DI / UDI-DI
- 00801741065330 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Surgical irrigation/aspiration pump, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical irrigation/aspiration pump, single-use
Simpulse by Davol Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration pump, single-use.
- StrykeFlow — Stryker Corp. · Class II
- Hydro-Surg — Davol Inc. · Class II
- SIMPULSE — Davol Inc. · Class II
- SIMPULSE — Davol Inc. · Class II
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- Hydro-Surg — Davol Inc. · Class II
- SIMPULSE — Davol Inc. · Class II
- X-Stream — Davol Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Davol Inc.
Sources (1)
- FDA UDI e50ee734-e842-45a0-a24a-c37c68ee91d6 36 fields · synced May 30, 2026