FDA.reportPublic FDA data

Surtex

Primary DI
05055445944360
Brand
Surtex
Company
SURTEX INSTRUMENTS LTD.
Model
OR-751-22
Device description
"Bone Lever 30 cm - 12"" Blade Width 22 mm Stainless Steel"
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055445944360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055445944360050554459443605055445944360

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+442081233513qa@surtex-instruments.co.uk

Regulatory Flags#

DUNS number
216232502
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055445900007SurtexSL-010-032026-05-12
05055445900014SurtexSL-010-042026-05-12
05055445900021SurtexSL-010-342026-05-12
05055445900038SurtexSL-012-032026-05-12
05055445900045SurtexSL-020-132026-05-12
05055445900052SurtexSL-020-142026-05-12
05055445900069SurtexSL-021-132026-05-12
05055445900076SurtexSL-021-142026-05-12
05055445900083SurtexSL-030-072026-05-12
05055445900090SurtexSL-030-172026-05-12
05055445900106SurtexSL-032-082026-05-12
05055445900113SurtexSL-032-092026-05-12
05055445900120SurtexSL-050-032026-05-12
05055445900137SurtexSL-052-032026-05-12
05055445900144SurtexSL-053-032026-05-12
05055445900151SurtexSL-056-032026-05-12
05055445900342SurtexSL-150-002026-05-12
05055445900359SurtexSL-200-002026-05-12
05055445900366SurtexSL-202-002026-05-12
05055445900373SurtexSL-204-002026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD6216030Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD6216060Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD6216080Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD907037100T0Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD9070451100Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD907075030Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD92268003T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268030T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268031T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268032T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268033T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268034T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268035T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268036T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268037T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268038T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268039T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268040T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268041T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268042T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268043T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268044T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268045T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268046T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268047T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268048T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD9147091800Surgical DirectSurgical Direct, Inc.GEG2026-07-09
00850083275822Intrace USAPILOTIS TECH LLCGEG2026-07-03
00850083275853Intrace USAPILOTIS TECH LLCGEG2026-07-03
008401944957383P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GEG2026-06-10