FDA.report

NYOrtho Padded Mitts

Primary DI
00811677010465
Brand
NYOrtho Padded Mitts
Company
N.Y. ORTHOPEDIC USA, INC.
Model
9370
Device description
NYOrtho Padded Mitts protect hands from unwanted picking and scratching. Options include dual-sided padding or one-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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FMQRestraint, Protective

Product Code Classifications

CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811677010465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811677010465008116770104658116770104650811677010465

GMDN Terms

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

Contacts

PhoneEmail
718-852-5330gudid@nyorthousa.com

Regulatory Flags

DUNS number
612083873
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

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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

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