FDA.report

XtractSR

Primary DI
05060766500133
Brand
XtractSR
Company
T.S.G. ASSOCIATES LLP
Model
72119
Catalog number
72119
Device description
Xtract™SR Stretcher with Base -72119
Published
2024-09-04
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
FPPStretcher, Hand-Carried

Product Code Classifications

CodeDeviceSpecialtyClass
FPPStretcher, Hand-CarriedGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060766500133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060766500133050607665001335060766500133

GMDN Terms

TermDefinition
Portable stretcherA manual device in the form of a portable lightweight platform or sheet with handles on which a patient can be carried in an emergency from an area inaccessible to a conventional ambulance stretcher. It may be designed as a folding stretcher, rescue backet, spine board, or evacuation sheet, and may include patient straps to secure/stabilize the patient. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
211458967
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05060766500096XtractSRXtractSR V4S2023-08-15
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