FDA.report

POSEY

Primary DI
20190676003482
Brand
POSEY
Company
POSEY PRODUCTS, LLC
Model
4126Q
Catalog number
4126Q
Device description
POSEY SR PADDED BELT
Published
2022-10-04
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

Related Records

Product Codes

CodeName
FMQRestraint, Protective

Product Code Classifications

CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20190676003482PackageGS124In Commercial Distribution
10190676003485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019067600348220190676003482
1019067600348510190676003485

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

Regulatory Flags

DUNS number
008503294
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DIBrandModelCatalogPublished
10190676008299Posey2555SS2555SS2025-07-16
30618125134718Grip-Lok3400LFC-10PK2024-12-02
00190676000616POSEY5707H5707H2016-09-13
00190676007653Posey8309WL8309WL2024-10-23
00190676000524POSEY800280022016-09-13
00190676000982POSEYA8070MA8070M2016-09-19
20190676008036POSEY819981992023-01-25
10190676007636POSEY8645WL8645WL2024-03-11
10190676007643POSEY8282WL8282WL2024-03-11
20190676007909POSEY8645WB8645WB2024-03-11
00190676000975POSEYA8070BA8070B2016-09-19
00190676000999POSEYA8070TFA8070TF2016-09-19
20190676007992POSEY8309SL068309SL062023-06-22
20190676008005POSEY8309SL128309SL122023-06-22
20190676008012POSEY8283SL068283SL062023-06-22
20190676008029POSEY8283SL128283SL122023-06-22
20190676007916POSEY8235NCPP128235NCPP122022-11-02
10618125190666POSEY8334WL8334WL2022-11-02
10190676000217POSEY574257422016-09-13
10190676000224POSEY574357432016-09-13

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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