MeroGel Otologic Packing 1x5cm 1517100

GUDID 08033549790776

MeroGel Otologic Packing is a space occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding and act as an adjunct to aid in the natural healing process.

Anika Therapeutics, Inc.

Intranasal splint, biodegradable
Primary Device ID08033549790776
NIH Device Record Key740e44a3-fa54-4883-a87d-3828dc43793a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeroGel Otologic Packing 1x5cm
Version Model Number651-142
Catalog Number1517100
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place T ≤ 40 C

Device Identifiers

Device Issuing AgencyDevice ID
GS108033549790776 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-12-21
Device Publish Date2018-02-19

On-Brand Devices [MeroGel Otologic Packing 1x5cm]

08033549791001MeroGel Otologic Packing is a space occupying dressing and/or stent intended to separate mucosal
08033549790776MeroGel Otologic Packing is a space occupying dressing and/or stent intended to separate mucosal

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