FDA.reportPublic FDA data

MaxMoreSpine

Primary DI
04260200313751
Brand
MaxMoreSpine
Company
Hoogland Spine Products GmbH
Model
1001-ABR 8
Device description
Reverse Curette, 3.0mm
Published
2022-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260200313751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260200313751042602003137514260200313751

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. 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
Serial number
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
04260200313034MaxMoreSpine1001-MDT-0012022-03-01

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B382SD9147092140Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096450Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096460Surgical DirectSurgical Direct, Inc.FZS2026-07-09
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B382SD9147096510Surgical DirectSurgical Direct, Inc.FZS2026-07-09
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B382SD9147096530Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096540Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096550Surgical DirectSurgical Direct, Inc.FZS2026-07-09
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