FDA.reportPublic FDA data

NYOrtho Resident Release Cushion Belts

Primary DI
00811677011387
Brand
NYOrtho Resident Release Cushion Belts
Company
N.Y. ORTHOPEDIC USA, INC.
Model
9704
Device description
Resident Release Cushion Belts help position the patient and provide added safety. Multiple closures are available including easy-on/easy-off quick-release buckles and one handed resident-friendly buckles.
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00811677011387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811677011387008116770113878116770113870811677011387

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
DM exempt
true
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
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
00748426263943Medline-MicrotekMicrotek Medical LLCFMQ2026-01-21
20884389198749MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-11-14
10190676008299PoseyPOSEY PRODUCTS, LLCFMQ2025-07-16
00749756399173DeRoyalDEROYAL INDUSTRIES, INC.FMQ2025-06-19
10810178883117ViveVIVE HEALTH LLCFMQ2025-05-19
10815614021115Elevate ArmBoard Extender HSemler Technologies, Inc.FMQ2025-05-19
10815614021122Elevate ArmBoard Extender H Semler Technologies, Inc.FMQ2025-05-19
00748426141128Medline-MicrotekMicrotek Medical LLCFMQ2025-04-08
06974737270125EMSSSHANGHAI EMSS MED&TECH CO.,LTD.FMQ2025-03-12
10815614021092mBrace 4285 Wrist Support with HookSemler Technologies, Inc.FMQ2025-02-27
00195278925428Pristina PaddleGE MEDICAL SYSTEMSFMQ2025-01-09
10888277673472MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-01-04
10197344112937MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-29
10197344112944MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-29
10197344112258MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-14
10888277699557MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-08-07
09010279001050iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
09010279001289iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
29010279001702iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
29010279001719iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
10810113577484ViveVIVE HEALTH LLCFMQ2024-07-17
00749756394567DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394574DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394581DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394598DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394604DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394611DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
06931918129979HALYARDGRI Medical & Electronic Technology Co., Ltd.FMQ2024-06-11
06931918189829HALYARDGRI Medical & Electronic Technology Co., Ltd.FMQ2024-06-11
50080196281372MedlineMEDLINE INDUSTRIES, INC.FMQ2024-05-01