FDA.report

NA

Primary DI
00848486016814
Brand
NA
Company
MAKO SURGICAL CORP.
Model
111618
Catalog number
111618
Device description
Leg Positioner Disposables Kit
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMPProtector, skin pressure
FQMBANDAGE, ELASTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848486016814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486016814008484860168148484860168140848486016814

GMDN Terms

TermDefinition
Orthopaedic knee/leg holder linerA sterile pad/cover designed to be placed between a patient's leg and an orthopaedic knee/leg holder, cushioning the leg to reduce the risk of damage of the skin/muscles/nerves during an orthopaedic procedure (e.g., arthroscopy, arthroplasty). It is typically made of disposable plastic material (e.g., a foam) with an appropriate shape and size to fit the holder. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
175239677
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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07613327627725MakoShoulder 1.0+TKA 2.0.1+TKA 1.0.3+THA 4.17000028873152026-03-10
07613327683653Shoulder 1.5 Installation Disk7000043787467000043787462026-03-03
07613327595482Scapular Clamp1906611906612026-01-30
07613327595567Robotic Arm Array MountRobotic Arm Array Mount2906502026-01-30
07613327595772Shoulder irrigation Clip, SterileShoulder irrigation Clip, Sterile1906812026-01-30
07613327623277Lower Tray, Mako Shoulder Tray7000026060227000026060222026-01-30
07613327623284Double Tier Tray Outer Shell7000026060117000026060112026-01-30
07613327625530MAKO Knee Tray Bottom Insert7000026060137000026060132026-01-30
07613327522006Mako7000006250597000006250592026-01-14
07613327595505Mako Glenoid RetractorSmall1906652026-01-08
07613327595741Black Probe1906641906642026-01-08
07613327523874Mako2104902104902025-02-06
07613327627220Mako1906711906712024-11-18
07613327627565Mako1025-200-0751025-200-0752024-11-18
07613327627572Mako1020-200-0751020-200-0752024-11-18
07613327626971Mako1.01906872024-11-15
07613327627213Mako1.01906702024-11-15
07613327625868INSTRUMENT7000021128907000021128902024-10-04
07613327625875INSTRUMENT7000021500957000021500952024-10-04
07613327624304NA2299992299992024-09-18

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