FDA.reportPublic FDA data

MaxMoreSpine

Primary DI
04260200310293
Brand
MaxMoreSpine
Company
Hoogland Spine Products GmbH
Model
1001-CS 002
Device description
Cervical Sleeve II 4,2 mm
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
FZYHammer, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZYHammer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260200310293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260200310293042602003102934260200310293

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. 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
04260200313034MaxMoreSpine1001-MDT-0012022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705034647616N/AMedos International SàrlFZY2026-07-09
00198506091179ELMED INCORPORATEDELMED INCORPORATEDFZY2026-06-03
00810189451162Surgical DesignSurgical Design, Inc.FZY2026-05-23
00810189451483Surgical DesignSurgical Design, Inc.FZY2026-05-23
00198506089114ELMED INCORPORATEDELMED INCORPORATEDFZY2026-04-02
00198506089411ELMED INCORPORATEDELMED INCORPORATEDFZY2026-04-02
10705034579023N/AMedos International SàrlFZY2026-03-05
00840493416472LUX Expandable Interbody SystemXENIX MEDICAL LLCFZY2026-02-24
03662663083638ActivLHighridge Medical, LLCFZY2026-02-03
03662663083645ActivLHighridge Medical, LLCFZY2026-02-03
03662663083652ActivLHighridge Medical, LLCFZY2026-02-03
03662663083669ActivLHighridge Medical, LLCFZY2026-02-03
03662663083676ActivLHighridge Medical, LLCFZY2026-02-03
03662663083690ActivLHighridge Medical, LLCFZY2026-02-03
03662663155618Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155762Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155779Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663244695Vital MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-12-18
04262494463150N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463174N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463167N/ADoppkon GmbH & Co. KGFZY2025-11-28
03662663216951Telluride MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-11-17
03662663267205Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663267601Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663279123Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
00196449034604Anatomic Access LLIFTyber Medical, LLCFZY2025-10-22
00198506085741ELMED INCORPORATEDELMED INCORPORATEDFZY2025-09-19
04059453096517Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFZY2025-08-25
04262494460562N/ADoppkon GmbH & Co. KGFZY2025-08-05
10889981322144REEF LSeaspine Orthopedics CorporationFZY2025-07-15