mi-eye Procedure Kit

GUDID 00861578000379

medical supplies kit for use during mi-eye procedures. contains off-the-shelf medical supplies.

TRICE MEDICAL, INC.

Surgical preparation kit
Primary Device ID00861578000379
NIH Device Record Key009c29d0-35e6-411c-9a2b-72c20d9c3ff3
Commercial Distribution StatusIn Commercial Distribution
Brand Namemi-eye Procedure Kit
Version Model NumberT900-001
Company DUNS009452895
Company NameTRICE MEDICAL, INC.
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 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

Phone610-989-8080
Emailcustomercare@tricemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100861578000379 [Primary]

FDA Product Code

KDDKit, Surgical Instrument, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-11-10

Devices Manufactured by TRICE MEDICAL, INC.

00857356008026 - mi-eye 22023-11-17 MI-EYE 2 SYSTEM, MI-ULTRA, EN
00857356008118 - mi-eye 22023-11-17 TRICE MI-EYE ANGLED NEEDLESCOPE, 120MM
00857356008224 - mi-tablet 32023-11-17 mi-tablet 3
00857356008231 - mi-eye 32023-11-17 mi-eye 3 needlescope, 95mm
00857356008248 - mi-eye 32023-11-17 mi-eye 3 angled scope, 120mm
00857356008255 - mi-eye 32023-11-17 mi-eye 3 25 deg scope, 75mm with cannula
00857356008262 - mi-eye 32023-11-17 mi-eye 3 scope, 95mm with cannula
00857356008279 - mi-eye 32023-11-17 mi-eye 3 25° scope, 75mm with cannula

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