FDA.reportPublic FDA data

N/A

Primary DI
00614138109551
Brand
N/A
Company
TETRA MEDICAL SUPPLY CORP.
Model
140112
Catalog number
140112
Device description
VINYL CAST BOOT, OPEN, MEDIUM
Published
2022-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPGShoe, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPGShoe, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614138109551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614138109551006141381095516141381095510614138109551

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
18006214041sales@tetramed.com

Regulatory Flags#

DUNS number
047580212
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614138106147N/A1213021213022022-08-19
00614138106161N/A1213041213042022-08-19
00614138107786N/A1299041299042022-08-09
00614138101203N/A2822002822002022-08-02
00614138114302N/A2824002824002022-08-02
00614138114258N/A2812-002812-002022-08-01
00614138114272N/A2816002816002022-08-01
00614138114289N/A2820002820002022-08-01
00614138107809N/A1299111299112022-07-29
00614138107816N/A1299121299122022-07-29
00614138107823N/A1299131299132022-07-29
00614138107830N/A1299141299142022-07-29
00614138121799N/A1458001458002022-07-30
00614138121805N/A1458011458012022-07-30
00614138121812N/A1458021458022022-07-30
00614138121829N/A1458031458032022-07-30
00614138121836N/A1458041458042022-07-30
00614138121843N/A1458101458102022-07-30
00614138121850N/A1458111458112022-07-30
00614138121867N/A1458121458122022-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G0648317270026770GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270026840GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270026910GAITKEEPER® Cast Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270027520Position Health® Classic Post-Op Shoe POSITION HEALTH, LLCIPG2024-08-27
G0648317270027690Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027760Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027830Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
G0648317270027900Position Health® Classic Post-Op ShoePOSITION HEALTH, LLCIPG2024-08-27
10810113576395CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576401CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576418CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113576425CoreTechVIVE HEALTH LLCIPG2024-06-10
10810113575978VIVEVIVE HEALTH LLCIPG2024-06-05
00810060883488Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
00810060883587Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
00810060883594Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
00810060888025Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
00810060888032Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
00810060888049Rhino MD ORTHOPAEDICS, INC.IPG2023-12-20
10810041980059ViveVIVE HEALTH LLCIPG2023-10-18
20810041980056ViveVIVE HEALTH LLCIPG2023-10-18
10810041980066ViveVIVE HEALTH LLCIPG2023-10-18
10810041980073ViveVIVE HEALTH LLCIPG2023-10-18
10810041980080ViveVIVE HEALTH LLCIPG2023-10-18
10810041980097ViveVIVE HEALTH LLCIPG2023-10-18
10810041980103ViveVIVE HEALTH LLCIPG2023-10-18
10810041980110ViveVIVE HEALTH LLCIPG2023-10-18
10810041980127ViveVIVE HEALTH LLCIPG2023-10-18
10810041980134ViveVIVE HEALTH LLCIPG2023-10-18
10818323029649ViveVIVE HEALTH LLCIPG2023-10-18