FDA.reportPublic FDA data

Knee arthroscopy support

Primary DI
07350111831455
Brand
Knee arthroscopy support
Company
Reison Medical AB
Model
10-353-18-B
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

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350111831455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350111831455073501118314557350111831455

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, reusableAn assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device.

Sterilization Methods#

Method table
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260217222176AMTRION Claw 4025Amtrion GmbHFWZ2026-05-26
00696588008257De Mayo Universal Distractor®Innovative Medical Products, IncFWZ2026-01-20
10653405986362CONMEDConmed CorporationFWZ2026-01-17
30653405986373CONMEDConmed CorporationFWZ2026-01-17
20653405990182CONMEDConmed CorporationFWZ2026-01-17
00696588008240De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-12-16
00696588008165De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-09-17
00696588008172De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-09-17
00696588008141De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-08-28
00696588008158De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-08-28
00696588008127De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-08-18
00696588008134De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-08-18
00696588008110De Mayo Universal Distractor®Innovative Medical Products, IncFWZ2025-08-11
00696588008073De Mayo Knee Positioner®Innovative Medical Products, IncFWZ2025-08-05
00696588008080De Mayo Knee Positioner®Innovative Medical Products, IncFWZ2025-08-05
00696588008097De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-07-28
00696588008103De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-07-28
00696588008066De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-06-30
00696588008035Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008042Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008059Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008028MorphBoard®Innovative Medical Products, IncFWZ2025-05-28
00696588007960MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007977MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007984MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007991MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588008004MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588008011MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00724995245016ClampSTERIS CORPORATIONFWZ2025-05-05
00696588007922UKnee Suspended Knee PositionerInnovative Medical Products, IncFWZ2025-04-09