Identity
- Trade Name
- StrykeFlow FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, reusable FDA UDI
- Device Name
- Adapter for Davol Nezhat/Dorsey Suction/Irrigation Probes with Three O-Rings FDA UDI
- Model / Reference
- 0250070435 FDA UDI
- Description
- Adapter for Davol Nezhat/Dorsey Suction/Irrigation Probes with Three O-Rings FDA UDI
Identifiers
- Catalog Number
- 250-070-435 FDA UDI
- Primary DI / UDI-DI
- 07613327051841 FDA UDI
- 510(k) Number
- K963646 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Surgical/emergency suction cannula, non-illuminating, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical/emergency suction cannula, non-illuminating, reusable
StrykeFlow by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/emergency suction cannula, non-illuminating, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- MicroFrance® — Integra Microfrance · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SCANLAN® Variable Suction Rotatable Tips — SCANLAN INTERNATIONAL INC · Class I
- Fukushima Tear Drop Suction Tube Straight Malleable 10 Fr. 21 cm - 8 1/4" Ø 3.3 mm — SURTEX INSTRUMENTS LTD · Class IIa
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class II
Cleared under the same submission
K963646 also covers:
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
- Stryker Corp.
Sources (1)
- FDA UDI 2fc11f8a-08e9-4f11-88f7-6d0145df2ca4 36 fields · synced May 30, 2026