FDA.report

Stratum Ankle

Primary DI
00810082893144
Brand
Stratum Ankle
Company
Medartis Inc.
Model
SAOLIVELGNS
Device description
Stratum Ankle Olive Wire Long non-sterile
Published
2023-06-01
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
true

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810082893144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810082893144008100828931448100828931440810082893144

GMDN Terms

TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
192756786
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
true

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00810082898392Calcshift Instrument System1031-100162024-11-27
00810082898521Calcshift Instrument System1031-100172024-11-27
00810082898538Calcshift Instrument System1031-100182024-11-27
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