FDA.reportPublic FDA data

OLH #BHS

Primary DI
03701602300280
Brand
OLH #BHS
Company
Innovative Orthopedic Technologies AG
Model
6813122
Catalog number
6813122
Device description
3-3 Ball - Heel Slider
Published
2026-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
03701602300280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701602300280037016023002803701602300280

GMDN Terms#

Term, Definition table
TermDefinition
Operating table orthopaedic extension, non-poweredA non-powered, orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder or spinal surgery, C- or O-arm use). It typically consists of height, length and angle adjustable supports or telescopic bars/plates (e.g., leg spar).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 409 658 1017info@iotiot.com

Regulatory Flags#

DUNS number
480626052
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701602300006ARCH Leg Positioning System6813010A6813010A2026-01-12
03701602300013ARCH Orthopedic Leg Positioner6813010B6813010B2026-01-12
03701602300020Distance Holding Fork681300168130012026-01-12
03701602300037The RAMP981100098110002026-01-12
03701602300044ARCH - Boot S32115391B32115391B2026-01-13
03701602300051ARCH - Boot M32115392B32115392B2026-01-13
03701602300068ARCH - Boot M32115392321153922026-01-13
03701602300075ARCH - Boot S32115391321153912026-01-13
03701602300105PURIST - Leg positioning system681310068131002026-01-13
03701602300112PURIST / OLH - Boot S - B6883360B6883360B2026-01-13
03701602300129PURIST / OLH - Boot M - B6883314B6883314B2026-01-13
03701602300136OLH #ERDP - B6813048B6813048B2026-01-13
03701602300143OLH #ERD - B6813041B6813041B2026-01-13
03701602300150OLH #ER - B6813035B6813035B2026-01-13
03701602300167OLH #BHA- B6813123B6813123B2026-01-13
03701602300174OLH #ED - B6813037B6813037B2026-01-13
03701602300181OLH - DENYER PLUS - B6813049B6813049B2026-01-13
03701602300198OLH - DENYER - B6813040B6813040B2026-01-13
03701602300204OLH - US/EU - B6813009B6813009B2026-01-13
03701602300211POP UNIVERSAL681340268134022026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
03701602300211POP UNIVERSALInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300228OLH #ERDPInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300235OLH #ERDInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300242OLH #ERInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300259MP XRAYCERInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300266DAA TOP 360Innovative Orthopedic Technologies AGBWN2026-01-13
03701602300273OLH #BHAInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300297OLH #EDInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300303OLH - DENYER PLUSInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300310OLH - DENYERInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300327OLH - US/EUInnovative Orthopedic Technologies AGBWN2026-01-13