FDA.reportPublic FDA data

Molteno M-Sphere

Primary DI
09419196000199
Brand
Molteno M-Sphere
Company
MOLTENO OPHTHALMIC LIMITED
Model
MS22
Catalog number
MS22
Device description
MS22 - Molteno M-Sphere® 22mm Natural Hydroxyapatite Orbital Implant
Published
2016-08-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HPZImplant, Eye Sphere

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPZImplant, Eye SphereOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09419196000199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09419196000199094191960001999419196000199

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, animal-derived, non-bioabsorbableA sterile non-bioabsorbable device made primarily of animal-derived bone matrix (e.g., heat-treated hydroxyapatite ceramic from animal cancellous bone) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowths of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, cylinders, or granules.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter22Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+6434792744info@molteno.com

Regulatory Flags#

DUNS number
760385075
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09419196000014MoltenoD1D12016-08-12
09419196000021MoltenoDL2DL22016-08-12
09419196000038MoltenoDR2DR22016-08-12
09419196000052MoltenoL2L22016-08-12
09419196000069MoltenoR2R22016-08-12
09419196000076MoltenoS1S12016-08-12
09419196000083MoltenoP1P12016-08-12
09419196000090Molteno3GS-175GS-1752016-08-12
09419196000106Molteno3GL-230GL-2302016-08-12
09419196000212Molteno3SS-185SS-1852016-08-12
09419196000229Molteno3SL-245SL-2452016-08-12
09419196000168Molteno M-SphereMS16MS162016-08-12
09419196000175Molteno M-SphereMS18MS182016-08-12
09419196000182Molteno M-SphereMS20MS202016-08-12
09419196000205Molteno MoaBoneMS08MS082016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13700773728111SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2026-02-17
13700773724397EZYPOR® Ø 18 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773724403EZYPOR® Ø 20 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773724410EZYPOR® Ø 22 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728081EZYPOR® Ø 16 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728852EZYPOR® Ø 12 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728890EZYPOR® Ø 14 mm FCI S A S FCI 20 22HPZ2024-06-21
B09114150010mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114151012mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114152014mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114153016mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114154018mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114155020mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114156022mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
03760087123715SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2021-05-30
13760087123712SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2021-05-30
03760087122435Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122442Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122459Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122466Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122473Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122480Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122510Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122527Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122916Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122923Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122930Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122954Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122961Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122985Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06