osmed Sphere Expander 352-7200

GUDID EOSM35272001

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 Sphere Expanders are used for expansion of the orbita at congenital anophthalmia and microphthalmia.

Osmed GmbH

Skin-port tissue expander
Primary Device IDEOSM35272001
NIH Device Record Key3829aaee-7872-49cc-9f88-e98a00add5b6
Commercial Distribution StatusIn Commercial Distribution
Brand Nameosmed Sphere Expander
Version Model Number2.0ml
Catalog Number352-7200
Company DUNS341784176
Company NameOsmed GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEOSM35272001 [Primary]

FDA Product Code

NFMExpander, Tissue, Orbital

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-23
Device Publish Date2017-04-28

On-Brand Devices [osmed Sphere Expander]

EOSM35275001osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
EOSM35274001osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
EOSM35273001osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
EOSM35272001osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
EOSM35271001osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry

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