FDA.reportPublic FDA data

Amtouch Air/Water Syringe Tips

Primary DI
00850048528864
Brand
Amtouch Air/Water Syringe Tips
Company
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
Model
Metal Core/White Tube - 250/Bag
Catalog number
AM001AW-WH
Device description
Air/Water Syringe Tips - Metal Core/White Tube - White (250/Bag)
Published
2024-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ECBUnit, Syringe, Air And/Or Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048528864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048528864008500485288648500485288640850048528864

GMDN Terms#

Term, Definition table
TermDefinition
Oral/enteral syringe drawing-up strawA flexible, blunt, tubular device intended to be connected to an oral/enteral syringe for the convenient transfer of fluids (e.g., dissolved medication, liquid nutrition) from an open container into the syringe prior to oral/enteral administration; it is not intended to puncture the seal of a vial/container, nor is it intended for patient contact. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
180611519
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048528987Amtouch Etchant Gel1.2ml (4 pack)AMETCH42024-05-15
00850048528994Amtouch Etchant Gel1.2ml (24 pack)AMETCH242024-05-15
00850058951003Amtouch Etchant GelJumbo Kit 25mlAMETCHJUMBO-KIT2024-05-15
00850058951010Amtouch Etchant GelJumbo Refill 25mlAMETCHJUMBO2024-05-15
00850048528338EvolusSSunsc3022023-07-03
00850048528352EvolusLSunsc3042023-07-03
00850048528345EvolusMSunsc3032023-07-03
10810109910356EvolusS/CaseSunsc302CS2023-07-03
10810109910363EvolusM/CaseSunsc303CS2023-07-03
10810109910370EvolusL/CaseSunsc304CS2023-07-03
00850058951232Amtouch ToothbrushesPrepasted - AdultAMTB-PP2024-10-17
00850058951249Amtouch Dental KitDental Hygiene Kit (5pc)AMDHK2024-10-17
00850058951256Amtouch Orthodontic KitOrthodontic Kit (8pc)AMOHK-AD2024-10-17
00850058951355Amtouch Orthodontic FlosspicksUnscented - WhiteAMOFP2024-10-17
00850048528925Amtouch Temporary Crown & Bridge MaterialA2AMTCBA22024-05-14
00850048528932Amtouch Temporary Crown & Bridge MaterialA1AMTCBA12024-05-14
00850048528901Amtouch Air/Water Syringe TipsColor Core/Clear Tube - 250/BagAM001AW2024-10-08
00850048528918Amtouch Air/Water Syringe TipsColor Core/Clear Tube - 1000/BagAM001AW-10002024-10-08
00850058951263Amtouch Intraoral TipsYellowAM-001IOYE2024-10-08
00850058951270Amtouch Intraoral TipsClearAM-001IOCL2024-10-08

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