FDA.reportPublic FDA data

MTI

Primary DI
10840118416396
Brand
MTI
Company
Medical Technology Industries, Inc.
Model
7001094-00-228
Catalog number
7001094-00-228
Device description
Leg Restraint Strap ULTRA-CHIANTI
Published
2022-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMQRestraint, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840118416396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084011841639610840118416396

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, reusableA non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
801-887-5114customer.service@mti.net

Regulatory Flags#

DUNS number
053947946
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840118422267MTI330-01-214330-01-2142020-02-03
10840118422274MTI330-01-217330-01-2172020-02-03
10840118422281MTI330-01-221330-01-2212020-02-03
10840118422298MTI330-01-238330-01-2382020-02-03
10840118422304MTI330-01-241330-01-2412020-02-03
10840118422311MTI330-01-218330-01-2182020-02-03
10840118422328MTI330-01-219330-01-2192020-02-03
10840118422335MTI330-01-239330-01-2392020-02-03
10840118422342MTI330-01-237330-01-2372020-02-03
10840118422359MTI330-01-240330-01-2402020-02-03
10840118422366MTI330-01-216330-01-2162020-02-03
10840118422373MTI330-01-220330-01-2202020-02-03
10840118422380MTI330-01-998330-01-9982020-02-03
10840118422397MTI330-01-215330-01-2152020-02-03
10840118422403MTI330-01-242330-01-2422020-02-03
10840118422410MTI330-01-222330-01-2222020-02-03
10840118422427MTI330-01-228330-01-2282020-02-03
10840118422434MTI330-01-236330-01-2362020-02-03
10840118422441MTI330-01-245330-01-2452020-02-03
10840118422458MTI330-01-244330-01-2442020-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196310128MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-06-03
10748426141125Medline-MicrotekMicrotek Medical LLCFMQ2025-04-08
00195278925428Pristina PaddleGE MEDICAL SYSTEMSFMQ2025-01-09
09010279001708iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
09010279001715iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
10080196281374MedlineMEDLINE INDUSTRIES, INC.FMQ2024-05-01
M1435040070Protective Vest No SleeveKenad SG Medical, Inc.FMQ2023-09-17
10190676003232POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676003348POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676003355POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005441POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005458POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005465POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676001016POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676001085POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676001108POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002518POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002525POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002532POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002549POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002556POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002563POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002570POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002594POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002600POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002617POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002624POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002631POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002693POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002709POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05