osmed Hemi Socket Expander EXH-1020

GUDID EOSMEXH10201

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 Hemi Socket Expanders are used for expansion of the connecting tissue sack at congenital anophthalmia and microphthalmia.

Osmed GmbH

Skin-port tissue expander
Primary Device IDEOSMEXH10201
NIH Device Record Key14733d53-96db-402d-a463-9191b24d5cbf
Commercial Distribution StatusIn Commercial Distribution
Brand Nameosmed Hemi Socket Expander
Version Model Number2.0ml
Catalog NumberEXH-1020
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
HIBCCEOSMEXH10201 [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 Date2015-10-02

On-Brand Devices [osmed Hemi Socket Expander]

EOSMEXH10201osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
EOSMEXH09181osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
EOSMEXH0814P1osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
EOSMEXH08141osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
EOSMEXH06111osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.