FDA.report

Four Post

Primary DI
00845699000586
Brand
Four Post
Company
SIZEWISE RENTALS, L.L.C.
Model
TRAP-4
Published
2018-10-17
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

Product Codes

CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications

CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845699000586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699000586008456990005868456990005860845699000586

GMDN Terms

TermDefinition
Bed traction frameAn adjustable support structure usually attached to a patient's bed and designed for management of various orthopaedic conditions. It typically consists of a steel tubing structure that includes brackets and/or pulleys; it includes a post for the headboard and/or footboard, and often an adjustable-length top bar or rail with a hanging trapeze. The device is designed for use in combination with weights and/or other attachments to produce the desired traction in patients while permitting some freedom of motion. It is used to treat patients with fractures and other orthopaedic disorders (e.g., of the lower or cervical spine, hip).

Sterilization Methods

Method

Regulatory Flags

DUNS number
967025602
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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00845699002429SizewiseBT48862024-09-20
00845699002436SizewiseMA39862024-09-20
00845699002443SizewiseMA48862024-09-20
00845699002450SizewiseBPUL 39862024-09-20
00845699002474SizewiseNP126 39802024-09-20
00845699002481SizewiseNP126 42802024-09-20
00845699002498SizewiseNP12G 3948802024-09-20
00845699002504SizewiseNPT3 G 39802024-09-20
00845699002511SizewiseNPT3 G 42802024-09-20
00845699002528SizewiseNPT3 G 48802024-09-20
00845699002535SizewiseNPT3 G 3948802024-09-20
00845699002597SizewiseENVY NPT335882024-09-20
00845699002603SizewiseENVY NP935882024-09-20
00845699002610SizewiseADP 35882024-09-20
00845699002627SizewiseADP PLAT35882024-09-20
00845699002634SizewiseADP LAL35882024-09-20
00845699002641SizewiseADP PULLAL35882024-09-20
00845699002658SizewiseADP ROLAL35882024-09-20
00845699002672SizewiseIMLAL 35802024-09-20

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