FDA.report

Retaining Pin Locking Lever Module 120°

Primary DI
09120116978435
Brand
Retaining Pin Locking Lever Module 120°
Company
I.T.S. GmbH
Model
1F0I055A-02
Catalog number
1F0I055A-02
Device description
Retaining Pin Locking Lever Module 120°
Published
2024-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09120116978435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09120116978435091201169784359120116978435

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep out of sunlight

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
303456917
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 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

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