FDA.reportPublic FDA data

MedE-Kast®

Primary DI
00809958010112
Brand
MedE-Kast®
Company
ACELL, INC.
Model
TCC2ULTRS
Catalog number
TCC2ULTRS
Device description
MedE-Kast® Ultra Total Cast System
Published
2018-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITGBANDAGE, CAST

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00809958010112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809958010112008099580101128099580101120809958010112

GMDN Terms#

Term, Definition table
TermDefinition
Cast foot coverA boot-like cover for a foot enclosed in a leg cast. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and removal. It may be known as a cast boot. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com
+1(800)826-2926customerservice@acell.com

Regulatory Flags#

DUNS number
137258252
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10381780486831MediHoney®31535315352018-08-28
10381780486886MediHoney®31815318152018-08-30
10381780486930MediHoney®31505315052019-03-06
10381780486978MediHoney®31805318052018-09-14
00386190002056MicroMatrix®MMFX05MMFX052023-10-02
00386190001820Cytal®WSR1625WSR16252019-12-16
00386190001837Cytal®WSR1635WSR16352019-12-16
00386190000007MatriStemMM0020MM00202017-01-10
00386190000014MatriStemMM0030MM00302017-01-10
00386190000052MatriStemWS0303WS03032017-01-10
00386190000076MatriStemWS0307WS03072017-01-10
00386190000090MatriStemWS0710WS07102017-01-10
00386190000113MatriStemWS1015WS10152017-01-10
00386190000137MatriStemMM0060MM00602017-01-10
00386190000151MatriStemMM0100MM01002017-01-10
00386190000168MatriStemMM0100FMM0100F2017-01-10
00386190000182MicroMatrix®MM0200MM02002017-01-10
00386190000199MatriStemMM0200FMM0200F2017-01-10

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Primary DI, Brand, Company table
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087114280529303M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280529543M™ Scotchcast™Solventum US LLCITG2026-04-18
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