PL8 47452516

GUDID 08052990970476

CITIEFFE SRL

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID08052990970476
NIH Device Record Keyf1266876-653e-48b7-bb3f-c2a222d1ebb1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePL8
Version Model NumberCortical screw ø2.5mm L16mm
Catalog Number47452516
Company DUNS431406875
Company NameCITIEFFE SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+39051721850
Emailinfo@citieffe.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108052990970476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-19
Device Publish Date2018-09-01

On-Brand Devices [PL8]

08051739534771Kirschner wire, ø1.2x120mm
08051739534764Drill bit, ø2.5x150mm
08051739534757Drill bit, ø1.9x150mm
08052990970636Drill guide, ø2.5mm
08052990972692Support screws, ø2.5mm
08052990971282Wrist instrument box, empty
08052990970308Wrist reconstruction plate, XL left
08052990970292Wrist reconstruction plate, XL right
08052990970285Wrist reconstruction plate, L left
08052990970278Wrist reconstruction plate, L right
08052990970261Wrist reconstruction plate, M left
08052990970254Wrist reconstruction plate, M right
08052990970247Wrist reconstruction plate, S left
08052990970230Wrist reconstruction plate, S right
08052990970575Kirschner wire, ø1.2x120mm
08052990970544Cortical screw ø2.5mm L30mm
08052990970537Cortical screw ø2.5mm L28mm
08052990970520Cortical screw ø2.5mm L26mm
08052990970513Cortical screw ø2.5mm L24mm
08052990970506Cortical screw ø2.5mm L22mm
08052990970490Cortical screw ø2.5mm L20mm
08052990970483Cortical screw ø2.5mm L18mm
08052990970476Cortical screw ø2.5mm L16mm
08052990970469Cortical screw ø2.5mm L14mm
08052990970452Cortical screw ø2.5mm L12mm
08052990970445Cortical screw ø2.5mm L10mm
08052990970438Cortical screw ø2.5mm L8mm
08052990970421Locking screw ø2.5mm L30mm
08052990970414Locking screw ø2.5mm L28mm
08052990970407Locking screw ø2.5mm L26mm
08052990970391Locking screw ø2.5mm L24mm
08052990970384Locking screw ø2.5mm L22mm
08052990970377Locking screw ø2.5mm L20mm
08052990970360Locking screw ø2.5mm L18mm
08052990970353Locking screw ø2.5mm L16mm
08052990970346Locking screw ø2.5mm L14mm
08052990970339Locking screw ø2.5mm L12mm
08052990970322Locking screw ø2.5mm L10mm
08052990970315Locking screw ø2.5mm L8mm

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