FDA.report

MaxMoreSpine

Primary DI
04260200313010
Brand
MaxMoreSpine
Company
Hoogland Spine Products GmbH
Model
1001-GW 006
Device description
Guide Wires 1.5mm; length 255 mm;
Published
2022-03-01
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
false

Related Records

Product Codes

CodeName
HXIPasser, Wire, Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260200313010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260200313010042602003130104260200313010

GMDN Terms

TermDefinition
Bone nail guidewire, reusableA long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
507292204
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04260200314079MaxMoreSpine1002-TS 0072022-08-31
04260200314086MaxMoreSpine1002-TS 0082022-08-31
04260200314093MaxMoreSpine1002-TS 0092022-08-31
04260200314109MaxMoreSpine1002-TS 0102022-08-31
04260200312525MaxMoreSpine1001-BE 001/H2022-08-02
04260200312532MaxMoreSpine1001-BE 001/S2022-08-02
04260200313096MaxMoreSpine1001-BE-0032022-08-02
04260200313102MaxMoreSpine1001-BE-0022022-08-02
04260200313119MaxMoreSpine1001-BE-0042022-08-02
04260200313690MaxMoreSpine1001-BE 004/S 2022-08-02
04260200313560MaxMoreSpine1001-IS 0122022-03-15
04260200313867MaxMoreSpine1001-IS 0142022-03-15
04260200313874MaxMoreSpine1001-DF 001-D2022-03-15
04260200313881MaxMoreSpine1001-DC 0182022-03-15
04260200313898MaxMoreSpine1001-EF 001/1M-D2022-03-15
04260200313904MaxMoreSpine1001-EF 003/1U2022-03-15
04260200313911MaxMoreSpine1001-EF 005/1B-D2022-03-15
04260200313928MaxMoreSpine1001-EF 0092022-03-15
04260200313935MaxMoreSpine1001-EF 009B-D2022-03-15
04260200313942MaxMoreSpine1001-EF 035B-D2022-03-15

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