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Thermo Scientific Forma

FDA UDI

Class II (US FDA UDI)

by Thermo Fisher Scientific (Asheville) LLC

Identity

Trade Name
Thermo Scientific Forma FDA UDI
Generic Name
Assisted reproduction freezer FDA UDI
Device Name
Controlled Rate Freezer FDA UDI
Model / Reference
7457 FDA UDI
Description
Controlled Rate Freezer FDA UDI

Identifiers

Catalog Number
7457 FDA UDI
Primary DI / UDI-DI
10815773020189 FDA UDI
510(k) Number
K021042 FDA UDI
FDA Product Code
MQG FDA UDI
GMDN Term
Assisted reproduction freezer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6120 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Assisted reproduction freezer

Thermo Scientific Forma by Thermo Fisher Scientific (Asheville) LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assisted reproduction freezer.

Cleared under the same submission

K021042 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thermo Fisher Scientific (Asheville) LLC

Sources (1)

  • FDA UDI 91538f64-892b-4dd6-b3e2-d56f09372a46 37 fields · synced Jun 9, 2026