FDA.reportPublic FDA data

Malleable Ear Dressing

Primary DI
00818501021154
Brand
Malleable Ear Dressing
Company
INVOTEC INTERNATIONAL, INC.
Model
90-20000
Catalog number
90-20000
Device description
Malleable Ear Dressing, Aluminum/Silicone
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ITGBandage, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818501021151PackageGS110In Commercial Distribution
00818501021154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081850102115110818501021151
00818501021154008185010211548185010211540818501021154

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-biodegradableA non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.

Regulatory Flags#

DUNS number
622812592
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818501023158Invotec Forceps 129-808002023-07-18
00818501021161Invotec Silicone Sheeting20-2068020-206802022-12-07
00818501021178Invotec Silicone Sheeting20-2068220-206822022-12-07
00818501021185Invotec Silicone Sheeting20-2068520-206852022-12-07
00818501021956Invotec PVA Nasal Dressing22-6040022-604002022-12-07
00818501021963Invotec PVA Nasal Dressing22-60400P22-60400P2022-12-07
00818501021970Invotec PVA Nasal Dressing22-6040222-604022022-12-07
00818501021987Invotec PVA Nasal Dressing22-60402P22-60402P2022-12-07
00818501021994Invotec PVA Nasal Dressing22-6040622-604062022-12-07
00818501022007Invotec PVA Nasal Dressing22-60406P22-60406P2022-12-07
00818501022014Invotec PVA Nasal Dressing22-6040922-604092022-12-07
00818501022021Invotec PVA Nasal Dressing22-60409P22-60409P2022-12-07
00818501022038Invotec PVA Nasal Dressing22-6041022-604102022-12-07
00818501022045Invotec PVA Nasal Dressing22-60410P22-60410P2022-12-07
00818501022052Invotec PVA Nasal Dressing22-6041122-604112022-12-07
00818501022069Invotec PVA Nasal Dressing22-60411P22-60411P2022-12-07
00818501022076Invotec PVA Nasal Dressing22-6041322-604132022-12-07
00818501022083Invotec PVA Nasal Dressing22-60413P22-60413P2022-12-07
00818501022090Invotec PVA Nasal Dressing22-6041422-604142022-12-07
00818501022106Invotec PVA Nasal Dressing22-6042122-604212022-12-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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087114280529303M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280529543M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280529923M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280530363M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280530503M™ Scotchcast™Solventum US LLCITG2026-04-18
10080196284191MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
10080196832330MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
10192253045864WebrilCardinal Health 200, LLCITG2025-09-23
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00840117344402"CurPro Undercast Padding, 100% Polyester, 4"" x 4 yd "Dynarex CorporationITG2025-06-05
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10885632106545MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-16
10885632106514MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
10885632106538MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
10197106823019CARDINAL HEALTHCardinal Health 200, LLCITG2024-12-04
10080196745616MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-13
10080196745661MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-13
10080196284184MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-12
10080196824779MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-12
10197106447994CARDINAL HEALTHCardinal Health 200, LLCITG2023-10-12
307073877914153M™ Scotchcast™3M COMPANYITG2022-12-08
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