Balloon Extractor

Primary DI
10855364004099
Brand
Balloon Extractor
Company
MAR-MED INC.
Model
BEX
Device description
Balloon Nasal Foreign Body Extractor
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBESnare, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBESnare, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855364004099PackageGS110In Commercial Distribution
00855364004092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085536400409910855364004099
00855364004092008553640040928553640040920855364004092

GMDN Terms#

Term, Definition table
TermDefinition
ENT foreign body inflatable extractorA non-sterile, manual device intended to be inserted into the nasal or ear canal for the extraction of a foreign body/debris. It is a thin tube with a proximal inflation mechanism (e.g., a syringe) and a distal balloon. The distal end is intended to be navigated past the foreign body, after which the balloon is inflated and then pulled back along the canal to dislodge the foreign body. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
616-454-3000info@marmed.com

Regulatory Flags#

DUNS number
176664068
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
00855364004146ZeroWetSuperShieldSS-100NS2025-05-15
00855364004153ZeroWetKlenzalacKL-10NS2025-05-15
00855364004115Rhino-Pak 45mmRP-452025-02-06
00855364004139Rhino-Pak 75mmRP-752025-02-06
10855364004112Rhino-Pak 45mmRP-452025-02-06
00855364004122Rhino-Pak 55mmRP-552025-02-06
10855364004136Rhino-Pak 75mmRP-752025-02-06
00855364004030Tourni-Cot - SmallTCS2020-09-23
00855364004047Tourni-Cot - MediumTCM2020-09-23
00855364004054Tourni-Cot - LargeTCL2020-09-23
00855364004085Tourni-Cot - UniversalTCU2020-09-23
00855364004061Tourni-Cot - Extra LargeTXL2020-09-23
00855364004108Derma-StentDMT2020-09-23
00855364004092Balloon ExtractorBEX2020-09-23
10855364004037Tourni-Cot - SmallTCS2020-09-23
10855364004068Tourni-Cot - Extra LargeTXL2020-09-23
10855364004105Derma-StentDMT2020-09-23

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G586E97726310Novo SurgicalNOVO SURGICAL, INC.KBE2023-12-18
00842962149355HNM MEDICALHNM STAINLESS, LLC.KBE2023-04-06
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