FDA.report

MaxMoreSpine

Primary DI
04260200310095
Brand
MaxMoreSpine
Company
Hoogland Spine Products GmbH
Model
1001-BD 001
Device description
Manual Bone Drill 4 mm, steril
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
true
Single use
true

Related Records

Product Codes

CodeName
HTWBit, Drill

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260200310095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260200310095042602003100954260200310095

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

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
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

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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