FDA.reportPublic FDA data

N/A

Primary DI
00614138112681
Brand
N/A
Company
TETRA MEDICAL SUPPLY CORP.
Model
160900
Catalog number
160900
Device description
ULTRALIGHT AFO BRACE, MALE RIGHT
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
ITWJoint, Ankle, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614138112681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614138112681006141381126816141381126810614138112681

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810178889808ViveVIVE HEALTH LLCITW2026-05-27
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00749756880169DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
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00749756888158DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00810113579801ViveVIVE HEALTH LLCITW2025-05-20
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00810113579429CoreTechVIVE HEALTH LLCITW2024-10-24
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