PIT'STOP®

GUDID 03760225713341

IN2BONES

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device ID03760225713341
NIH Device Record Key4bfcb87c-b760-4ef9-90c4-505b5e05b36b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIT'STOP®
Version Model NumberM20 SP011
Company DUNS263616749
Company NameIN2BONES
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+33472292626
Emailcontact@in2bones.com

Device Dimensions

Width11 Millimeter
Length13.3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103760225713341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-02-19
Device Publish Date2018-04-20