Identity
- Trade Name
- Strata™ FDA UDI
- Generic Name
- Ventriculoperitoneal shunt FDA UDI
- Device Name
- SHUNT 27822 STRATA II SNP ASSY SM BIO FDA UDI
- Model / Reference
- 27822 FDA UDI
- Description
- SHUNT 27822 STRATA II SNP ASSY SM BIO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169975668 FDA UDI
- 510(k) Number
- K060681 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Ventriculoperitoneal shunt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 90.0 Centimeter FDA UDI
Category: Ventriculoperitoneal shunt
The Strata device is a highly effective and reliable implantable ventriculoperitoneal shunt designed to manage increased intracranial pressure, particularly in patients with hydrocephalus. This innovative medical device provides a safe and controlled environment for cerebrospinal fluid (CSF) diversion, allowing it to be absorbed into the body and alleviating symptoms of elevated intracranial pressure.
Similar devices
Also classified as Ventriculoperitoneal shunt.
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- Integra® — Integra Lifesciences Corp. · Class II
- Novus™ — Integra Lifesciences Corp. · Class II
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- CODMAN® UNI-SHUNT® — Integra LifeSciences Production Corporation · Class II
Cleared under the same submission
K060681 also covers:
- Strata II Adjustment Kit — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic PS Medical
Sources (1)
- FDA UDI 655b51d2-f335-412c-951a-57992893100b 36 fields · synced Jul 24, 2026