FDA.reportPublic FDA data

Clamping Bolt

Primary DI
09120047297162
Brand
Clamping Bolt
Company
I.T.S. GmbH
Model
118003-13
Catalog number
118003-13
Device description
Clamping Bolt, Distal Femur a. Tibia
Published
2018-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120047297162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120047297162091200472971629120047297162

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming armA surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
303456917
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120047301241Cannulated Tibia Nail11210-36011210-3602016-09-14
09120047301364Cannulated Tibia Nail11209-28511209-2852016-09-14
09120047301371Cannulated Tibia Nail11209-30011209-3002016-09-14
09120047301388Cannulated Tibia Nail11209-40511209-4052016-09-14
09120047301395Cannulated Tibia Nail11210-28511210-2852016-09-14
09120047301418Cannulated Tibia Nail11209-33011209-3302016-09-14
09120047301425Cannulated Tibia Nail11209-34511209-3452016-09-14
09120047301432Cannulated Tibia Nail11209-36011209-3602016-09-14
09120047301449Cannulated Tibia Nail11209-37511209-3752016-09-14
09120047301456Cannulated Tibia Nail11209-39011209-3902016-09-14
09120047301692Cannulated Tibia Nail11210-31511210-3152016-09-14
09120047301722Cannulated Tibia Nail11210-33011210-3302016-09-14
09120047301739Cannulated Tibia Nail11210-34511210-3452016-09-14
09120047301968Cannulated Tibia Nail11209-31511209-3152016-09-14
09120047302118Cannulated Tibia Nail11210-39011210-3902016-09-14
09120047302156Cannulated Femur Nail, Right12110-30012110-3002016-09-14
09120047302163Cannulated Femur Nail, Left12210-30012210-3002016-09-14
09120047302194Cannulated Femur Nail, Right12112-30012112-3002016-09-14
09120047302200Cannulated Femur Nail, Left12212-30012212-3002016-09-14
09120047303214Cannulated Femur Nail, Right12112-42012112-4202016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344138897NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
00192896122697Cooley Vascular ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00192896122710Debakey Coarctation ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00192896122727Debakey Coarctation ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00884450846032Safeguard Radial™Merit Medical Systems, Inc.DXC2026-02-20
00840479401027enableCV IntraClude™ Intra-Aortic Occlusion DeviceENABLECV INC.DXC2026-02-06
18022057015881DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015891DeTACH Aortic Cross Clamp Head- MediumCORCYM SRLDXC2026-02-03
18022057015904DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
08022057015914DeTACH Aortic Cross Clamp Delivery SystemCORCYM SRLDXC2026-02-03
08022057015921DeTACH Aortic Cross Clamp Quick Release DeviceCORCYM SRLDXC2026-02-03
08022057015945DeTACH Aortic Cross Clamp Delivery DeviceCORCYM SRLDXC2026-02-03
00810123209507Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209514Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209521Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209538Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209545Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209552Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209583Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209590Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209606Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209613Adler Instrument CompanyAdler, Inc.DXC2025-08-19
54026704930840PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930857PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930864PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930871PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930888PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930895PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
00192896121638Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17
00192896121645Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17