MEROGEL 2pk 4x4cm 1517002

GUDID 08033549791117

Merogel is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery, and in otologic packing, to act as an adjunct to aid in the natural healing process.

Anika Therapeutics, Inc.

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Primary Device ID08033549791117
NIH Device Record Key7a0842e4-bb5b-4ef6-9aab-32138b54b427
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEROGEL 2pk 4x4cm
Version Model Number651141
Catalog Number1517002
Company DUNS807613393
Company NameAnika Therapeutics, Inc.
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
GS108033549791117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMXBalloon, Epistaxis

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-26
Device Publish Date2024-04-18

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08033549791117 - MEROGEL 2pk 4x4cm2024-04-26 Merogel is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery, and in otologic packing, to act as an adjunct to aid in the natural healing process.
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