FDA.reportPublic FDA data

NYOrtho Dual Padded Mitts

Primary DI
00811677012094
Brand
NYOrtho Dual Padded Mitts
Company
N.Y. ORTHOPEDIC USA, INC.
Model
9371
Device description
NYOrtho Dual Padded Mitts protect hands from unwanted picking and scratching. Dual-sided padding combined with breathable mesh fabric to provide additional comfort for hands. Wrist tie closure enables use without arm movement control straps.
Published
2023-07-10
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
00811677012094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811677012094008116770120948116770120940811677012094

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
718-852-5330gudid@nyorthousa.com

Regulatory Flags#

DUNS number
612083873
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810114602911NYOrtho Wheelchair Cushion Foam 16x16x49595-1616042023-10-05
00811677011998NYOrtho Wheelchair Cushion Foam 18x16x49595-1816042023-10-05
00811677012025NYOrtho Wheelchair Cushion Foam 18x16x29595-1816022023-10-05
00811677012063NYOrtho Wheelchair Cushion Foam 18x16x39595-1816032023-10-05
00811677017495NYOrtho Wheelchair Cushion Foam 16x16x39595-1616032023-10-05
00811677017525NYOrtho Wheelchair Cushion Foam 18x18x29595-1818022023-10-05
00811677019611NYOrtho Wheelchair Cushion Foam 16x18x29595-1618022023-10-05
00811677019628NYOrtho Wheelchair Cushion Foam 16x18x39595-1618032023-10-05
00810114600245NYOrtho Wheelchair Cushion Gel-Foam 20x20x29595-GEL-2020022023-09-03
00810114600252NYOrtho Wheelchair Cushion Gel-Foam 22x20x29595-GEL-2220022023-09-03
00810114600269NYOrtho Wheelchair Cushion Gel-Foam 22x22x29595-GEL-2222022023-09-03
00810114600276NYOrtho Wheelchair Cushion Gel-Foam 22x22x39595-GEL-2222032023-09-03
00810114600283NYOrtho Wheelchair Cushion Gel-Foam 26x18x29595-GEL-2618022023-09-03
00810114600290NYOrtho Wheelchair Cushion Gel-Foam 28x18x29595-GEL-2818022023-09-03
00810114600306NYOrtho Wheelchair Cushion Gel-Foam 30x18x39595-GEL-3018032023-09-03
00810114601648NYOrtho Wheelchair Cushion Gel-Foam 34x20x49595-GEL-3420042023-09-03
00811677011868NYOrtho Wheelchair Cushion Foam 16x16x29595-1616022023-09-03
00811677012001NYOrtho Wheelchair Cushion Gel-Foam 18x18x39595-GEL-1818032023-09-03
00811677012032NYOrtho Wheelchair Cushion Gel-Foam 20x16x39595-GEL-2016032023-09-03
00811677012049NYOrtho Wheelchair Cushion Gel-Foam 22x18x29595-GEL-2218022023-09-03

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
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
10810087352766CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353022CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353039CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353046CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353053CoulmedCoulmed Products Group LLCFMQ2023-01-06
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