SYN03.312.241

GUDID 10888551045469

MAXFRAME FOOT PLATE, 120MM LONG

STERILMED, INC.

External orthopaedic fixation system reprocessed component
Primary Device ID10888551045469
NIH Device Record Key516e6ad1-3e22-40dc-bc98-b050620d1664
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSYN03.312.241
Catalog NumberSYN03.312.241
Company DUNS175899459
Company NameSTERILMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110888551045469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888551045469]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-25
Device Publish Date2019-11-15

Devices Manufactured by STERILMED, INC.

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10888551045186 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
10888551045193 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
10888551045209 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
10888551010313 - NA2021-01-22 KNIFE SET ECTRA II (PACK OF 3)
10888551021531 - NA2021-01-22 KNIVES (1) HOOK BLADE (1) TRIANGLE BLADE ENDOTRAC BLADE SYSTEM
10888551000048 - NA2020-11-06 CTS RELIEF KIT, 5PC SET
10888551012928 - NA2020-10-19 ENDO LUNG

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