Identity
- Trade Name
- CryotopUS-scoop(B) FDA UDI
- Generic Name
- Assisted reproduction vitrification carrier FDA UDI
- Device Name
- Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos. FDA UDI
- Model / Reference
- CryotopUS-scoop(B) FDA UDI
- Description
- Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos. FDA UDI
Identifiers
- Catalog Number
- 81198 FDA UDI
- Primary DI / UDI-DI
- 04582231462872 FDA UDI
- 510(k) Number
- K181469 FDA UDI
- FDA Product Code
- MQK FDA UDI
- GMDN Term
- Assisted reproduction vitrification carrier 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
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: Assisted reproduction vitrification carrier
CryotopUS-scoop(B) by Kitazato Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assisted reproduction vitrification carrier.
- S-CRYOLOCK (B) — BIOTECH INCORPORATED · Class II
- VitriGuard — Origio A/S · Class II
- Serological Pipette 1 mL — BIRR Biosciences BV · Class IIa
- Dry Incubator / EC6S-230MR — ASTEC CO.,Ltd · Class IIa
- CRYOPETTE — ORIGIO INC. · Class II
- Kryo 500 Series Controlled Rate Freezer — PLANER LIMITED · Class I
- VitriGuard — Origio A/S · Class II
- CRYOPETTE — ORIGIO INC. · Class II
Cleared under the same submission
K181469 also covers:
- CryotopUS-flash(B) — KITAZATO CORPORATION
- CryotopUS-flash(G) — KITAZATO CORPORATION
- CryotopUS-flash(R) — KITAZATO CORPORATION
- CryotopUS-flash(W) — KITAZATO CORPORATION
- CryotopUS-flash(Y) — KITAZATO CORPORATION
- CryotopUS-scoop(G) — KITAZATO CORPORATION
- CryotopUS-scoop(R) — KITAZATO CORPORATION
- CryotopUS-scoop(W) — KITAZATO CORPORATION
- CryotopUS-scoop(Y) — KITAZATO CORPORATION
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
- Kitazato Corporation
Sources (1)
- FDA UDI 0240470d-d023-483a-89a8-3f69e24c7570 35 fields · synced May 29, 2026