FDA.report

Locking Screw,Ø5x100mm, PPS

Primary DI
09120116973706
Brand
Locking Screw,Ø5x100mm, PPS
Company
I.T.S. GmbH
Model
1U1-5-100A-S
Catalog number
1U1-5-100A-S
Device description
Locking Screw,Ø5x100mm, PPS
Published
2024-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09120116973706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09120116973706091201169737069120116973706

GMDN Terms

TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep out of sunlight

Sterilization Methods

Method

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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