FDA.report

N/A

Primary DI
00614138109889
Brand
N/A
Company
TETRA MEDICAL SUPPLY CORP.
Model
140402
Catalog number
140402
Device description
DELUXE POST-OP SHOE MALE MEDIUM
Published
2022-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KNPOrthosis, Corrective Shoe

Product Code Classifications

CodeDeviceSpecialtyClass
KNPOrthosis, Corrective ShoePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614138109889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00614138109889006141381098896141381098890614138109889

GMDN Terms

TermDefinition
Cast shoe, reusableA footwear designed to be worn over a foot that is encased in a cast in order to protect the cast material and add stability for the patient while ambulating. Its foot bed provides comfort when ambulating and it may or may not protect the toes. It is available in a variety of designs and sizes and can be typically used both indoors and outdoors; some types may be used without a cast, e.g., in the case of a toe fracture. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
18006214041sales@tetramed.com

Regulatory Flags

DUNS number
047580212
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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