FDA.reportPublic FDA data

MaxMoreSpine

Primary DI
04260200313034
Brand
MaxMoreSpine
Company
Hoogland Spine Products GmbH
Model
1001-MDT-001
Device description
MaxDisc trephine
Published
2022-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260200313034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260200313034042602003130344260200313034

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
507292204
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260200310774MaxMoreSpine1001-GW 0012022-03-01
04260200310781MaxMoreSpine1001-GW 0022022-03-01
04260200310798MaxMoreSpine1001-GW 0032022-03-01
04260200312624MaxMoreSpine1001-GW 003N2022-03-01
04260200313010MaxMoreSpine1001-GW 0062022-03-01
04260200313539MaxMoreSpine1001-GW 0082022-03-01
04260200310064MaxMoreSpine1001-AI 0032022-02-28
04260200310323MaxMoreSpine1001-CW 0012022-02-28
04260200314031MaxMoreSpine1001-BD 003C2022-03-15
04260200310187MaxMoreSpine1001-BD 0062022-03-01
04260200310194MaxMoreSpine1001-BD 0072022-03-01
04260200311061MaxMoreSpine1001-TR 0022022-03-01
04260200311078MaxMoreSpine1001-TS 0012022-03-01
04260200311085MaxMoreSpine1001-TS 0022022-03-01
04260200311092MaxMoreSpine1001-TS 0032022-03-01
04260200311542MaxMoreSpine1001-TS 004-12022-03-01
04260200312570MaxMoreSpine1001-CT 002A2022-03-01
04260200312594MaxMoreSpine1001-DR 0012022-03-01
04260200312600MaxMoreSpine1001-DR 0022022-03-01
04260200313072MaxMoreSpine1001-TS 0052022-03-01

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Primary DI, Brand, Company table
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