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STERILE CBS 0.3 ML STRAW FOR SPERM WITHOUT JACKET WITH WHITE PLUG - 5x20
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 010288
Identity
- Trade Name
- CBS™ High Security Sperm Straw EUDAMEDSTERILE CBS 0.3 ML STRAW FOR SPERM WITHOUT JACKET WITH WHITE PLUG - 5x20 FDA UDI
- Generic Name
- Tissue cryostorage straw vitrification set FDA UDI
- Device Name
- CBS™ High Security Sperm Straw sterile with white plug - 0,3 ml (5 x 20) EUDAMED
- Model / Reference
- 010288 EUDAMED1 FDA UDI
Identifiers
- Catalog Number
- 010288 FDA UDI
- Primary DI / UDI-DI
- 03661532000325 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03661532000325 EUDAMED
- 510(k) Number
- K002595 FDA UDI
- FDA Product Code
- MQG FDA UDI
- EMDN Code
- U08020401 CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- Tissue cryostorage straw vitrification set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6120 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
STERILE CBS 0.3 ML STRAW FOR SPERM WITHOUT JACKET WITH WHITE PLUG - 5x20 by Cryo Bio System — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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 0.5 ML STRAW FOR SPERM WITH COTTON PLUG / 5 x 20 — CRYO BIO SYSTEM · Class II
Cleared under the same submission
K002595 also covers:
- CBS HIGH SECURITY EMBRYO AND SPERM STRAW/5x4x1 — CRYO BIO SYSTEM
- 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 0.3ML 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cryo Bio System
Sources (2)
- FDA UDI a93b715b-adbe-4a44-b40a-139a7e159053 34 fields · synced Jul 8, 2026
- EUDAMED 18a8a0d4-24f3-485d-8358-a1fb443ba365 61 fields · synced Jul 8, 2026