FDA.reportPublic FDA data

MaxMoreSpine

Primary DI
04260200310804
Brand
MaxMoreSpine
Company
Hoogland Spine Products GmbH
Model
1001-GW 004
Device description
Guide Wire Dispenser
Published
2022-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260200310804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260200310804042602003108044260200310804

GMDN Terms#

Term, Definition table
TermDefinition
Guidewire holderA sterile tubular device intended to be used for the storage and retrieval of one or more guidewires within the sterile field during a procedure. It is typically a long (approximately three metres) tube, that can be secured to surgical drapes, with a funnel-shaped proximal end and sometimes a sealed, vented distal end. This is a single-use 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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800037575173ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
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