FDA.reportPublic FDA data

ION ESPS ARM FIXATION SYSTEM

Primary DI
00860006375911
Brand
ION ESPS ARM FIXATION SYSTEM
Company
Infinitus Medical Technologies LLC
Model
IONESPS-2000
Published
2024-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BWNTable And Attachments, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006375911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006375911008600063759118600063759110860006375911

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
00860003986844GENESIS BI-WING XL GEN 3.0FPLS-3000-XLFPLS-3000-XL2026-10-15
00860014205507PNEUMA GENESIS BI-WIUNG POSITIONING SYSTEMNUMA-GENNUMA-GEN2026-10-15
00860014205514TruBlu HDP Bootliners722060192026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning System722060172026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning System722060182026-06-05
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
00860003986882HADRON FPLS INFINITY, HDPFPLS-1000-HDPFPLS-1000-HDP2024-07-17
00860003986899HADRON FPLS INFINITY, XLFPLS-1100FPLS-11002024-07-17
00860006375904KYBER SCC OFFSET UNIVERSAL RETRACTION POST SYSTEMKSSC-1000-1KSSC-1000-12024-07-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995363321NASTERIS CORPORATIONBWN2026-10-08
00724995363338NASTERIS CORPORATIONBWN2026-10-08
00724995363345NASTERIS CORPORATIONBWN2026-10-08
00724995363352NASTERIS CORPORATIONBWN2026-10-08
00724995363888NASTERIS CORPORATIONBWN2026-10-08
00724995363895NASTERIS CORPORATIONBWN2026-10-08
00842102116506StrongArm Surgical Holders and PositionersFLEXBAR MACHINE CORPORATIONBWN2026-10-07
00815849025615Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.BWN2026-10-06
00851674008683SmartSurface Riser - Stryker D860Elucent Medical, Inc.BWN2026-09-28
00842102116469Flexarm Surgical Holders and PositionersFLEXBAR MACHINE CORPORATIONBWN2026-08-03
00842180148864ELMED INCORPORATEDELMED INCORPORATEDBWN2026-06-08
00724995232030NASTERIS CORPORATIONBWN2026-05-26
10381780542254MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
10381780542261MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
03701602300044ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300051ARCH - Boot MInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300068ARCH - Boot MInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300075ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300099Velcro Strap longInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300105PURIST - Leg positioning systemInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300112PURIST / OLH - Boot S - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300129PURIST / OLH - Boot M - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300136OLH #ERDP - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300143OLH #ERD - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300150OLH #ER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300167OLH #BHA- BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300174OLH #ED - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300181OLH - DENYER PLUS - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300198OLH - DENYER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300204OLH - US/EU - BInnovative Orthopedic Technologies AGBWN2026-01-13