Identity
- Trade Name
- S-CRYOLOCK (C) FDA UDI
- Generic Name
- Assisted reproduction vitrification carrier FDA UDI
- Device Name
- S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos FDA UDI
- Model / Reference
- S-CL (C) FDA UDI
- Description
- S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos FDA UDI
Identifiers
- Catalog Number
- S-CL (CLEAR) FDA UDI
- Primary DI / UDI-DI
- B056SCLC1 FDA UDI
- 510(k) Number
- K122982 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
Radiation Sterilization FDA UDI
Category: Assisted reproduction vitrification carrier
S-Cryolock (c) by Biotech Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Assisted reproduction vitrification carrier.
- VitriGuard — Origio A/S · Class II
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- 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
- iDAScore — Vitrolife A/S · Class I
Cleared under the same submission
K122982 also covers:
- CRYOLOCK(C) — BIOTECH INCORPORATED
- CRYOLOCK(O) — BIOTECH INCORPORATED
- CRYOLOCK(Y) — BIOTECH INCORPORATED
- Cryolock(B) — BIOTECH INCORPORATED
- Cryolock(G) — BIOTECH INCORPORATED
- S-CRYOLOCK (B) — BIOTECH INCORPORATED
- S-CRYOLOCK (G) — BIOTECH INCORPORATED
- S-CRYOLOCK (O) — BIOTECH INCORPORATED
- S-CRYOLOCK (Y) — BIOTECH INCORPORATED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Biotech Incorporated
Sources (2)
- FDA UDI 265ef6a5-4f07-48cb-8a09-5b7d5879185c 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026