FDA.report

PF Apositioning Instrument

Primary DI
09120116974741
Brand
PF Apositioning Instrument
Company
I.T.S. GmbH
Model
1F0I165A
Catalog number
1F0I165A
Device description
PF Apositioning Instrument
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
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09120116974741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09120116974741091201169747419120116974741

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. 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

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