osmed Hemisphere Expander 352-6040

GUDID EOSM35260401

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.

Osmed GmbH

Skin-port tissue expander

• Primary Device ID: EOSM35260401
• NIH Device Record Key: 175375dd-afb1-407f-a15c-cbf4b6f6d23b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: osmed Hemisphere Expander
• Version Model Number: 0.4ml
• Catalog Number: 352-6040
• Company DUNS: 341784176
• Company Name: Osmed GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EOSM35260401 [Primary]

FDA Product Code

• NFM: Expander, Tissue, Orbital

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-23
• Device Publish Date: 2017-04-28

On-Brand Devices [osmed Hemisphere Expander]

• EOSM35262001: osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
• EOSM35261501: osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
• EOSM3526090P1: osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
• EOSM35260901: osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry
• EOSM35260401: osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacry