FDA.reportPublic FDA data

HADRON FPLS INFINITY, HDP

Primary DI
00860003986882
Brand
HADRON FPLS INFINITY, HDP
Company
Infinitus Medical Technologies LLC
Model
FPLS-1000-HDP
Catalog number
FPLS-1000-HDP
Published
2024-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003986882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003986882008600039868828600039868820860003986882

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient positioning set, single-useA collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent patient sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: padded positioners dedicated to a body part such as arm, leg, shoulder, neck, or feet positioner, a headrest, a non-slip pad/bolster placed underneath the patient (e.g., cervical notch), and securing devices (e.g., straps). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079575412
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014205514TruBlu HDP Bootliners840-000142026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning System840-000072026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning System840-000082026-06-05
00195893164608AXILLARY POSITIONING ROLLAXR-20002025-07-25
00195893397556AZUL, ITPWAZUL-20002025-07-25
00860006375959LUNA SUPINE PAD SYSTEMSP-35002025-07-25
00860006375966KIT, CHEST PAD AND STRAPCHST-30002025-07-25
00195893257713GENESIS BI-WING AAPFPLS-2000IHS-1T2:122024-07-17
00195893509492VISIWRAP SURGICAL FACE PROTECTORVWP-1000VWP-10002024-07-17
00860003986868GENESIS BI-WING AAP, XLFPLS-2100FPLS-21002024-07-17
00860003986875HADRON FPLS INFINITYFPLS-1000FPLS-10002024-07-17
00860003986899HADRON FPLS INFINITY, XLFPLS-1100FPLS-11002024-07-17
00860006375904KYBER SCC OFFSET UNIVERSAL RETRACTION POST SYSTEMKSSC-1000-1KSSC-1000-12024-07-17
00860006375911ION ESPS ARM FIXATION SYSTEMIONESPS-20002024-07-17
00860006375928ION ESPS ARM FIXATION SYSTEMDP-01DP-012024-07-17
00860006375935ION ESPS ARM FIXATION SYSTEMFM02-IFFM02-IF2024-07-17
00860006375942ION ESPS ARM FIXATION SYSTEMFM03-IFFM03-IF2024-07-17
00860003986806GENESIS BI-WING APP GEN 3.0FPLS-3000FPLS-30002024-07-16
00860003986813HADRON FPLS INFINITY GEN 3.0FPLS-3000-PADFPLS-3000-PAD2024-07-16
00860003986837GENESIS BI-WING AAP WINGSET, GEN 3.0FPLS-3000-WING2024-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014205514TruBlu HDP BootlinersInfinitus Medical Technologies LLCCCX2026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05