FDA.reportPublic FDA data

ANATOMICAL NASAL PACK WITH AIRWAY (polyvinyl alcohol sponge)

Primary DI
00821925030459
Brand
ANATOMICAL NASAL PACK WITH AIRWAY (polyvinyl alcohol sponge)
Company
Gyrus Acmi, Inc.
Model
70890742
Published
2018-09-13
Public version status
Update
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
EMXBALLOON, EPISTAXIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925030459PackageGS16In Commercial Distribution
00821925037175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925030459008219250304598219250304590821925030459
00821925037175008219250371758219250371750821925037175

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 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.

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
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002098USA Elite SystemEOS-HCF252024-07-25
00821925002111USA Elite SystemERIS-CF252024-07-25
00821925002128USA Elite SystemERIS-CF272024-07-25
00821925002159USA Elite SystemERLB-7.52024-07-25
00821925002166USA Elite SystemEROS-CF252024-07-25
00821925002173USA Elite SystemEROS-CF272024-07-25
00821925002586Gyrus ACMI1942024-07-25
00821925007482Gyrus ACMIRFG-31152024-07-25
00821925008076Bovie5686012024-07-25
00821925008083Bovie5686042024-07-25
00821925008458Bovie5686052024-07-25
00821925008908Gyrus ACMIG2152-322024-07-25
00821925009523IRRI-FLO I 59200002024-07-25
00821925011427DIEGO703390502024-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10855364004112Rhino-Pak 45mmMAR-MED INC.EMX2025-02-06
00855364004122Rhino-Pak 55mmMAR-MED INC.EMX2025-02-06
10855364004136Rhino-Pak 75mmMAR-MED INC.EMX2025-02-06
00821925030831Gyrus ACMIGyrus ACMI, LLCEMX2024-11-26
00821925022379Gyrus ACMIGyrus Acmi, Inc.EMX2024-07-25
30886158012222Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012239Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012246Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012253Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012260Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012284Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012291Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012314Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012321Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012338Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012345Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012352Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012369Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012376Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012383Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012390Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012406Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012437Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012444Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012451Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013243Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013267Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013274Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013281Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013298Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27