FDA.reportPublic FDA data

N/A

Primary DI
00614138109926
Brand
N/A
Company
TETRA MEDICAL SUPPLY CORP.
Model
140412
Catalog number
140412
Device description
DELUXE POST-OP SHOE FEMALE 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNPOrthosis, Corrective Shoe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNPOrthosis, Corrective ShoePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614138109926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614138109926006141381099266141381099260614138109926

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614138016040N/A1212021212022022-08-19
00614138016057N/A1212031212032022-08-19
00614138016064N/A1212041212042022-08-19
00614138016071N/A1212051212052022-08-19
00614138016088N/A1212061212062022-08-19
00614138025332N/A12007P12007P2022-08-19
00614138025349N/A12007N12007N2022-08-19
00614138105119N/A1214101214102022-08-19
00614138105126N/A1214111214112022-08-19
00614138105133NA1214121214122022-08-19
00614138105140N/A1214131214132022-08-19
00614138105157N/A1214141214142022-08-19
00614138105164N/A1214151214152022-08-19
00614138106147N/A1213021213022022-08-19
00614138106161N/A1213041213042022-08-19
00614138113428N/A2149-012149-012022-08-19
00614138113435N/A2149-022149-022022-08-19
00614138113442N/A2149-032149-032022-08-19
00614138113459N/A2149-042149-042022-08-19
00614138113466N/A2149-062149-062022-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178886319CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886326CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886333CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886340CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886357CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886364CoreTechVIVE HEALTH LLCKNP2026-02-03
00810060888582Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
00810060888599Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
00810060888605Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
06978785665087InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-12-08
06978785665094InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-12-08
00810195430755CadenseCadense, Inc.KNP2025-08-18
06978785665025InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-07-09
10810178880161ViveVIVE HEALTH LLCKNP2025-07-08
10810178880178ViveVIVE HEALTH LLCKNP2025-07-08
10810178880185ViveVIVE HEALTH LLCKNP2025-07-08
10810178880192ViveVIVE HEALTH LLCKNP2025-07-08
10810178880208ViveVIVE HEALTH LLCKNP2025-07-08
00810195430557CadenseCadense, Inc.KNP2025-07-08
00810195430564CadenseCadense, Inc.KNP2025-07-08
00810195430571CadenseCadense, Inc.KNP2025-07-08
00810195430588CadenseCadense, Inc.KNP2025-07-08
00609271120167POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120174POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120181POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120198POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120204POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120211POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120228POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120235POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15