Aquaplast RT™ RT-1804

GUDID 10841962114018

Aquaplast RT Sheet, 24" x 36", 3.2mm, Solid, XS

Qfix

Patient positioning thermoplastic mould material

Primary Device ID	10841962114018
NIH Device Record Key	bf5f4bb5-fad6-4938-8f54-915fb0e61fb6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Aquaplast RT™
Version Model Number	RT-1804
Catalog Number	RT-1804
Company DUNS	808875397
Company Name	Qfix
Device Count	5
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch
Width	36 Inch
Depth	3.2 Millimeter
Length	24 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962114001 [Primary]
GS1	10841962114018 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K935067

FDA Product Code

IYE	Accelerator, linear, medical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-12-24
Device Publish Date	2021-12-16

On-Brand Devices [Aquaplast RT™]

10841962111185	Aquaplast RT Head Only BoS, 2.4mm Standard Perf
10841962111161	Aquaplast RT Head Only BoS, 2.4mm Standard Perf
10841962110355	Aquaplast Orfit 4-Point, 2.4mm
10841962110348	Aquaplast Orfit 3-Point, Std, 2.4mm
10841962110331	Aquaplast PR 5-Point, 2.4mm Locks
10841962110324	Aquaplast PR 4-Point, 2.4mm Locks
10841962110317	Aquaplast PR 3-Point, Std, 2.4mm Locks
10841962110300	Aquaplast Orfit 5-Point, 2.4mm
10841962110294	Aquaplast Orfit 4-Point, 2.4mm
10841962110287	Aquaplast Orfit 3-Point, Std, 2.4mm
10841962110102	Aquaplast Orfit 4-Point Pelvis, 3.2mm
10841962110096	Aquaplast PR 5-Point, 2.4mm Locks
10841962110089	Aquaplast PR 3-Point, Std, 2.4mm Locks
10841962110072	Aquaplast PR 2-Point, 2.4mm Locks
10841962110065	Aquaplast Orfit 5-Point, 2.4mm
10841962112243	Aquaplast RT PR 4-Point, 2.4mm Locks
10841962112229	Aquaplast RT PR 4-Point, 2.4mm Locks
10841962112212	Aquaplast RT PR 4-Point, 2.4mm
10841962112199	Aquaplast RT PR 4-Point, 2.4mm
10841962112182	Aquaplast RT PR 3-Point, Std, 2.4mm Locks
10841962112168	Aquaplast RT PR 3-Point, Std, 2.4mm Locks
10841962112151	Aquaplast RT PR 3-Point, Std, 2.4mm
10841962112137	Aquaplast RT PR 3-Point, Std, 2.4mm
10841962112120	Aquaplast RT 20cm Chin Strap
10841962112106	Aquaplast RT 20cm Chin Strap
10841962112090	Aquaplast RT PR 2-Point, 2.4mm
10841962112076	Aquaplast RT PR 2-Point, 2.4mm
10841962112069	Aquaplast RT Orfit 5-Point, 2.4mm
10841962112045	Aquaplast RT Orfit 5-Point, 2.4mm
10841962112038	Aquaplast RT Orfit 4-Point, 2.4mm
10841962112014	Aquaplast RT Orfit 4-Point, 2.4mm
10841962112007	Aquaplast RT Orfit 3-Point, Std, 2.4mm
10841962111987	Aquaplast RT Orfit 3-Point, Std, 2.4mm
10841962111703	Aquaplast RT Sheet, 18" x 24", 2.4mm
10841962111680	Aquaplast RT Sheet, 18" x 24", 2.4mm
10841962111529	Aquaplast RT Sheet, 2.4mm, 18" x 24", Solid
10841962111505	Aquaplast RT Sheet, 2.4mm, 18" x 24", Solid
10841962111499	Aquaplast RT Sheet, 18" x 24", 2.4mm, Solid
10841962111475	Aquaplast RT Sheet, 18" x 24", 2.4mm, Solid
10841962111468	Aquaplast RT Slim U-Frame, Ext, 1.6mm
10841962111444	Aquaplast RT Slim U-Frame, Ext, 1.6mm
10841962111437	Aquaplast RT Cosmas Cup, Size E
10841962111413	Aquaplast RT Cosmas Cup, Size E
10841962111383	Aquaplast RT Cosmas Cup, Size D
10841962111369	Aquaplast RT Cosmas Cup, Size D
10841962111352	Aquaplast RT Cosmas Cup, Size C
10841962111338	Aquaplast RT Cosmas Cup, Size C
10841962111321	Aquaplast RT Cosmas Cup, Size B
10841962111307	Aquaplast RT Cosmas Cup, Size B
10841962113868	Aquaplast RT Sheet, 12" x 18", 2.4mm, Perf