FDA.report

Aquaplast RT™

Primary DI
10841962102121
Brand
Aquaplast RT™
Company
Qfix
Model
RT-1889X
Catalog number
RT-1889X
Device description
Aquaplast U-Frame, Ext , 3.2mm
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

Related Records

Contact Domains

Product Codes

CodeName
IYEAccelerator, linear, medical

Product Code Classifications

CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841962102121PrimaryGS10
10841962102138Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084196210212110841962102121
1084196210213810841962102138

GMDN Terms

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

TypeValueUnit
Depth3.2Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(610)268-0585Compliance@qfix.com
+16102680585Compliance@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

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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
00841962119580InfinityLock™RT-4800-04-DPRT-4800-04-DP2025-07-09

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