osmed Hemisphere Expander

Primary DI
EOSM35260401
Brand
osmed Hemisphere Expander
Company
Osmed GmbH
Model
0.4ml
Catalog number
352-6040
Device description
osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacrylate-n-vinylpyrrolidone-co-polymer) using the osmotic principle to expand physiological tissue space due to the absorption of body fluid from the surrounding tissues. The osmed Hemisphere Expanders are used for expansion of the connecting tissue sack at congenital anophthalmia and microphthalmia.
Published
2017-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NFMExpander, Tissue, Orbital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFMExpander, Tissue, OrbitalOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EOSM35260401PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Skin-port tissue expanderAn expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341784176
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EOSM35260901osmed Hemisphere Expander0.9ml352-60902017-04-28
EOSM3526090P1osmed Hemisphere Expander0.9ml parallel352-6090/P2017-04-28
EOSM35261501osmed Hemisphere Expander1.5ml352-61502017-04-28
EOSM35262001osmed Hemisphere Expander2.0ml352-62002017-04-28
EOSM35271001osmed Sphere Expander1.0ml352-71002017-04-28
EOSM35272001osmed Sphere Expander2.0ml352-72002017-04-28
EOSM35273001osmed Sphere Expander3.0ml352-73002017-04-28
EOSM35274001osmed Sphere Expander4.0ml352-74002017-04-28
EOSM35275001osmed Sphere Expander5.0ml352-75002017-04-28
EOSMEXH06111osmed Hemi Socket Expander0.4mlEXH-06112015-10-02
EOSMEXH08141osmed Hemi Socket Expander0.9mlEXH-08142015-10-02
EOSMEXH0814P1osmed Hemi Socket Expander0.9ml parallelEXH-0814P2015-10-02
EOSMEXH09181osmed Hemi Socket Expander1.5mlEXH-09182015-10-02
EOSMEXH10201osmed Hemi Socket Expander2.0mlEXH-10202015-10-02
EOSMEXS1021osmed Orbital Expander2.0mlEXS-1022015-10-02
EOSMEXS1031osmed Orbital Expander3.0mlEXS-1032015-10-02
EOSMEXS1041osmed Orbital Expander4.0mlEXS-1042015-10-02
EOSMEXS1051osmed Orbital Expander5.0mlEXS-1052015-10-02
EOSMEXS1061osmed Orbital Expander1.0mlEXS-1062015-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EOSM35260901osmed Hemisphere ExpanderOsmed GmbHNFM2017-04-28
EOSM3526090P1osmed Hemisphere ExpanderOsmed GmbHNFM2017-04-28
EOSM35261501osmed Hemisphere ExpanderOsmed GmbHNFM2017-04-28
EOSM35262001osmed Hemisphere ExpanderOsmed GmbHNFM2017-04-28
EOSM35271001osmed Sphere ExpanderOsmed GmbHNFM2017-04-28
EOSM35272001osmed Sphere ExpanderOsmed GmbHNFM2017-04-28
EOSM35273001osmed Sphere ExpanderOsmed GmbHNFM2017-04-28
EOSM35274001osmed Sphere ExpanderOsmed GmbHNFM2017-04-28
EOSM35275001osmed Sphere ExpanderOsmed GmbHNFM2017-04-28
EOSMEXH06111osmed Hemi Socket ExpanderOsmed GmbHNFM2015-10-02
EOSMEXH08141osmed Hemi Socket ExpanderOsmed GmbHNFM2015-10-02
EOSMEXH0814P1osmed Hemi Socket ExpanderOsmed GmbHNFM2015-10-02
EOSMEXH09181osmed Hemi Socket ExpanderOsmed GmbHNFM2015-10-02
EOSMEXH10201osmed Hemi Socket ExpanderOsmed GmbHNFM2015-10-02
EOSMEXS1021osmed Orbital ExpanderOsmed GmbHNFM2015-10-02
EOSMEXS1031osmed Orbital ExpanderOsmed GmbHNFM2015-10-02
EOSMEXS1041osmed Orbital ExpanderOsmed GmbHNFM2015-10-02
EOSMEXS1051osmed Orbital ExpanderOsmed GmbHNFM2015-10-02
EOSMEXS1061osmed Orbital ExpanderOsmed GmbHNFM2015-10-02