FDA.report

MaxMoreSpine

Primary DI
04260200313331
Brand
MaxMoreSpine
Company
Hoogland Spine Products GmbH
Model
1001-BDSS-01
Device description
Manual Bone Step-Drill 3 mm - 4.5 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
HTWBit, Drill

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260200313331PrimaryGS10

GMDN Terms

TermDefinition
Bone trephineAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. 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
false
Serial number
true
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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