Product Code: LPZ FDA unclassified

Container, Frozen Donor Tissue Storage

Unknown

The Frozen Donor Tissue Storage Container is a device used to store frozen biological tissue from human donors, such as bone, skin, or other grafts, under controlled low-temperature conditions to preserve viability until use. This device is currently unclassified (Class U) by the FDA, meaning it has not yet been placed into a final regulatory classification category and its regulatory pathway is pending. The product code is LPZ; no regulation number or specific medical specialty is recorded for this entry. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LPZ
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K021702	CRYOBAG, MODEL CB	Aug 06, 2002	Substantially Equivalent	Origen Biomedical, Inc.
K915471	CRYOBAG	Mar 02, 1994	Substantially Equivalent	Janus Biomedical, Inc.
K863872	TAMPER HAMPER	Feb 10, 1987	Substantially Equivalent	Hydro-Med Products, Inc.
K861761	ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE	Aug 28, 1986	Substantially Equivalent	Travenol Laboratories, S.A.
K860511	AMPU-PAK	Aug 04, 1986	Substantially Equivalent	Ammerman Medical Enterprises, Inc.
K853663	ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR	Apr 09, 1986	Substantially Equivalent	Travenol Laboratories, S.A.