Polyaxial Drill Guide Sleeve MDS100801

GUDID 10812269021989

Polyaxial Drill Guide Sleeve for K-Wire Ø1.1mm

MIAMI DEVICE SOLUTIONS LLC

Surgical drill guide, reusable
Primary Device ID10812269021989
NIH Device Record Key988bd623-d45d-4a3b-abbe-da207e92a4de
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolyaxial Drill Guide Sleeve
Version Model NumberMDS100801
Catalog NumberMDS100801
Company DUNS078703080
Company NameMIAMI DEVICE SOLUTIONS LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(786) 422-1400
Emailcustomerservice@miamidevicesolutions.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110812269021989 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10812269021989]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2017-06-26

On-Brand Devices [Polyaxial Drill Guide Sleeve ]

10812269021989Polyaxial Drill Guide Sleeve for K-Wire Ø1.1mm
10812269020425Polyaxial Drill Guide Sleeve for K-Wire Ø1.6mm

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