MedSource Fracture Kit Not Applicable

GUDID 00816703026236

Deluxe Fracture Kit

MEDSOURCE INTERNATIONAL LLC

First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable First aid limb splint, non-mouldable, reusable
Primary Device ID00816703026236
NIH Device Record Keybae7f96a-9091-4d70-9ee3-ae92548a0cab
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedSource Fracture Kit
Version Model NumberMS-2312_USA-RCS
Catalog NumberNot Applicable
Company DUNS041674552
Company NameMEDSOURCE INTERNATIONAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816703026236 [Primary]

FDA Product Code

CCXSupport, Patient Position

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

On-Brand Devices [MedSource Fracture Kit]

00840155408128Deluxe Fracture Care Kit (8) Splints
00816703026236Deluxe Fracture Kit
00816703026212Deluxe Fracture Care Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.