Identity
- Trade Name
- CBS HIGH SECURITY EMBRYO AND SPERM STRAW/5x4x1 FDA UDI
- Generic Name
- Tissue cryostorage straw vitrification set FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 025292 FDA UDI
- Primary DI / UDI-DI
- 03661532002954 FDA UDI
- 510(k) Number
- K002595 FDA UDI
- FDA Product Code
- MQK FDA UDI
- GMDN Term
- Tissue cryostorage straw vitrification set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6160 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
No
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: Tissue cryostorage straw vitrification set
CBS HIGH SECURITY EMBRYO AND SPERM STRAW/5x4x1 by Cryo Bio System — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue cryostorage straw vitrification set.
- CBS STERILE HIGH SECURITY TUBE BY 50 UNITS — CRYO BIO SYSTEM · Class II
- STERILE CBS 0.5 ML STRAW FOR SPERM WITH BLUE COTTON PLUG / 5 X 20 — CRYO BIO SYSTEM · Class II
- STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND BLUE FLEXIBLE ROD / BLISTER 5X15 — CRYO BIO SYSTEM · Class II
- CBS STERILE FILLING NOZZLE - BOX 100 — CRYO BIO SYSTEM · Class II
- STERILE 0.5 ML CBS STRAW FOR SPERM WITH COTTON PLUG / 4x5 — CRYO BIO SYSTEM · Class II
- STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND GREEN FLEXIBLE ROD / BLISTER 5X15 — CRYO BIO SYSTEM · Class II
- CBS STERILE HIGH SECURITY TUBE BY 20 UNITS — CRYO BIO SYSTEM · Class II
- STERILE CBS 0.3 ML STRAW FOR SPERM WITHOUT JACKET WITH WHITE PLUG - 5x20 — CRYO BIO SYSTEM · Class II
Cleared under the same submission
K002595 also covers:
- CBS STERILE HIGH SECURITY TUBE BY 20 UNITS — CRYO BIO SYSTEM
- CBS STERILE HIGH SECURITY TUBE BY 50 UNITS — CRYO BIO SYSTEM
- STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND BLUE FLEXIBLE ROD / BLISTER 5X15 — CRYO BIO SYSTEM
- STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND GREEN FLEXIBLE ROD / BLISTER 5X15 — CRYO BIO SYSTEM
- STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND PURPLE FLEXIBLE ROD / BLISTER 5X1 — CRYO BIO SYSTEM
- STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND RED FLEXIBLE ROD / BLISTER 5X15 — CRYO BIO SYSTEM
- STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND WHITE FLEXIBLE ROD / BLISTER 5X15 — CRYO BIO SYSTEM
- STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND YELLOW FLEXIBLE ROD / BLISTER 5X1 — CRYO BIO SYSTEM
- STERILE 0.5 ML CBS STRAW FOR SPERM WITH COTTON PLUG / 4x5 — CRYO BIO SYSTEM
- STERILE CBS 0.3 ML STRAW FOR SPERM WITHOUT JACKET WITH WHITE PLUG - 5x20 — CRYO BIO SYSTEM
- STERILE CBS 0.3ML STRAW FOR SPERM WITHOUT JACKET WHITE PLUG - 4X5 — CRYO BIO SYSTEM
- STERILE CBS 0.5 ML STRAW FOR SPERM WITH BLUE COTTON PLUG / 5 X 20 — CRYO BIO SYSTEM
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
- Cryo Bio System
Sources (1)
- FDA UDI 3b833f88-9edb-4ba3-8a11-158615e2533e 34 fields · synced Jun 8, 2026