FDA.reportPublic FDA data

Aquaplast RT™

Primary DI
10841962103142
Brand
Aquaplast RT™
Company
Qfix
Model
RT-1779R
Catalog number
RT-1779R
Device description
Aquaplast RT Reloadable Insert, Std, 2.4mm
Published
2016-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841962103142PrimaryGS10
10841962103159Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084196210314210841962103142
1084196210315910841962103159

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning thermoplastic mould materialA thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heating in hot water and while softened, are moulded around the patient's anatomy. When cooled, it hardens to form a custom-made mould or cast of that part of the body. After the moulding process is complete, it is typically attached to a board, frame, or another patient positioning system (PPS) or immobilization device. After application, this device cannot be reused (i.e., remoulded).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth2.4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(610)268-0585Compliance@qfix.com

Regulatory Flags#

DUNS number
808875397
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00841962120562FibreplastRT-A182KYSDNRT-A182KYSDN2026-05-26
00841962120456Alta for HexaPODRT-4800-05RT-4800-052026-01-14
00841962120388Lumen AirShuttleXT-5100-80XT-5100-802025-12-02
00841962120395Symphony Locating Bar, PH StyleRT-5100-11PHRT-5100-11PH2025-12-02
00841962120401Portrait Head Only Mask Adapter for Access SupineRT-4546-03RT-4546-032025-12-02
00841962120418Portrait Head & Neck Mask Adapter for Access SupineRT-4546-04RT-4546-042025-12-02
10841962119464Symphony Locating Bar, PH StyleRT-5100-11PHRT-5100-11PH2025-10-23
00841962119856IntegraBiteRT-A001RT-A0012025-11-13
00841962120340Edge Guide SystemRT-5100-55RT-5100-552025-09-11
00841962119467Alpine StirrupsRT-5100-54LRT-5100-54L2025-07-09
00841962119474Alpine StirrupsRT-5100-54RRT-5100-54R2025-07-09
00841962119481Symphony™RT-5100-48RT-5100-482025-07-09
00841962119498AirDrive Trolley™RT-5100-12RT-5100-122025-07-09
00841962119504Access Arm SupportRT-4546AA-01RT-4546AA-012025-07-09
00841962119511Access Wrist SupportRT-4546AW-01RT-4546AW-012025-07-09
00841962119528AirShuttle Locating BarRT-5100-11ERT-5100-11E2025-07-09
00841962119535AirShuttle Locating BarRT-5100-11RT-5100-112025-07-09
00841962119542AirShuttle Transfer HandleRT-5100-10-BRT-5100-10-B2025-07-09
00841962119559InfinityLock™RT-5100-10-ART-5100-10-A2025-07-09
00841962119573AirShuttle Transfer HandleRT-5100-10RT-5100-102025-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120562FibreplastQfixIYE2026-05-26
00840510401108KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510401115KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510401122KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510401139KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510400088KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-17
00840510401085KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-16
00840510401092KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-16
00817355028111KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-13
00850072631035ChartCheckRadformation, IncIYE2026-03-13
00850072631059ChartCheckRadformation, IncIYE2026-03-13
00860001672770ClearCheck V2Radformation, IncIYE2026-03-13
00860001672794EZFluenceRadformation, IncIYE2026-03-13
00840510401054KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
00840510401061KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
00840510401078KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
10840277411812Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
00840510401030KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-06
00840510401047KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-06
00817355029149KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-04
00840510401016KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-02
00817355027855KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-27
00817355028265KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-27
00817355024120KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-23
00817355028968KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-23
00817355029040KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-23
00817355024878KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18
00817355025363KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18
00817355025431KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18
00817355026971KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18