FDA.report

MaxMoreSpine

Primary DI
04260200310224
Brand
MaxMoreSpine
Company
Hoogland Spine Products GmbH
Model
1001-BH 001
Device description
Ball Handle
Published
2022-02-28
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
HXCWrench

Product Code Classifications

CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260200310224PrimaryGS10

GMDN Terms

TermDefinition
Manual surgical rotary handpiece, reusableA manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. 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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