Nasal Sponges Sterile

Primary DI
00840117340206
Brand
Nasal Sponges Sterile
Company
Dynarex Corporation
Model
3168
Device description
"Sterile-R, 3.14"" x 1.18"" x 0.59"" (8.0 cm x 3.0 cm x 1.5 cm)"
Published
2024-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00840117324763PackageGS1100In Commercial Distribution
00840117340268PackageGS13In Commercial Distribution
00840117340206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117324763008401173247638401173247630840117324763
00840117340268008401173402688401173402680840117340268
00840117340206008401173402068401173402060840117340206

GMDN Terms#

Term, Definition table
TermDefinition
Nasal haemostatic catheterA tubular device intended to be inserted into the nose to control nose bleeding (epistaxis) by direct pressure. It is typically a single-lumen tube with a sponge attached near its distal tip, and may include an integral airway that allows the patient to breathe through the nose while the catheter is in place. Some designs consist of a double-lumen with a balloon attached to each distal end to be used simultaneously in both nasal cavities and can also be used to stabilize zygomatic arch fractures. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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