FDA.report

Leg strap

Primary DI
07350111832155
Brand
Leg strap
Company
Reison Medical AB
Model
10-468-L
Published
2022-04-30
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
FWZOperating Room Accessories Table Tray

Product Code Classifications

CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07350111832155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07350111832155073501118321557350111832155

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
356766220
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
true
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
07350111830007Accessory clamp10-3012022-04-30
07350111830014Accessory clamp10-301-UK2022-04-30
07350111830021Accessory clamp10-301-US2022-04-30
07350111830038Accessory clamp10-3022022-04-30
07350111830045Accessory clamp10-302-P2022-04-30
07350111830052Radial clamp10-3042022-04-30
07350111830069Radial clamp10-304-P2022-04-30
07350111830076Radial clamp10-3052022-04-30
07350111830083Radial clamp10-305-P2022-04-30
07350111830090Radial clamp10-305-UK2022-04-30
07350111830106Radial clamp10-305-UK-P2022-04-30
07350111830113Radial clamp10-305-US2022-04-30
07350111830120Radial clamp10-305-US-P2022-04-30
07350111830137Radial clamp MIX10-3072022-04-30
07350111830151Radial clamp MIX10-307-P2022-04-30
07350111830168Radial clamp MIX10-307-UK2022-04-30
07350111830175Radial clamp MIX10-307-UK-P2022-04-30
07350111830182Radial clamp MIX10-307-US2022-04-30
07350111830199Radial clamp MIX10-307-US-P2022-04-30
07350111830205Radial clamp UNI10-3082022-04-30

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