SPI50085-014

GUDID 10888551034746

DRILL BIT TWIST

STERILMED, INC.

Fluted surgical drill bit, single-use, sterile
Primary Device ID10888551034746
NIH Device Record Keyf4171829-2a99-410e-8e4f-9b6bbe856807
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSPI50085-014
Catalog NumberSPI50085-014
Company DUNS175899459
Company NameSTERILMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110888551034746 [Primary]

FDA Product Code

HTWBIT, DRILL

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


[10888551034746]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-07
Device Publish Date2020-04-29

Devices Manufactured by STERILMED, INC.

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10888551045704 - Reprocessed DECANAV EP Catheter, F Curve2024-11-25 Reprocessed DECANAV EP Catheter, F Curve, 7Fr, 115cm, Electrodes: 11, SP:2-8-2mm, Tip Length: 2.4mm, Pin Connector:34
10888551045179 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
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
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