FDA.reportPublic FDA data

DISPOSABLE SHAH AURAL DRESSING

Primary DI
00821925022966
Brand
DISPOSABLE SHAH AURAL DRESSING
Company
Gyrus Acmi, Inc.
Model
890075
Published
2018-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925022966PackageGS16In Commercial Distribution
00821925034846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925022966008219250229668219250229660821925022966
00821925034846008219250348468219250348460821925034846

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical drapeA protective covering made of natural or synthetic materials, or both, designed to isolate a surgical site from contamination (e.g., microbial, substance) during an ear/nose/throat (ENT) procedure. It will typically be shaped for this purpose. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925043916SOLTIVETFL-FBX150BS2024-08-01
00821925043930SOLTIVETFL-FBX200S2024-08-01
00821925043978SOLTIVETFL-FBX200BS2024-08-01
00821925043992SOLTIVETFL-FBX365S2024-08-01
00821925044074SOLTIVETFL-FBX940S2024-08-01
00821925000933Gyrus ACMI207142024-07-25
00821925025929DIEGO701390002024-07-25
00821925025936DIEGO701390022024-07-25
00821925025974DIEGO701390102024-07-25
00821925025967DIEGO701390082024-07-25
00821925000469Gyrus ACMI005-5-1012024-07-25
00821925000476Gyrus ACMI005-5-2012024-07-25
00821925000483Gyrus ACMI005-5-3012024-07-25
00821925000490Gyrus ACMI005-5-4012024-07-25
00821925010932Gyrus ACMI608BX2024-07-25
00821925025943DIEGO701390042024-07-25
00821925022379Gyrus ACMI8909122024-07-25
00821925010819Gyrus ACMI7035-30062024-07-25
00821925043077DIEGO ELITEBB4000SC2024-07-25
00821925043879SOLTIVETFL-FBX150S2024-07-25

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