9971

GUDID 10888551000048

CTS RELIEF KIT, 5PC SET

STERILMED, INC.

Scalpel blade, single-use
Primary Device ID10888551000048
NIH Device Record Keyb45761fc-3a0b-414b-8066-1b6844d2cf67
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberLIN9971
Catalog Number9971
Company DUNS175899459
Company NameSTERILMED, INC.
Device Count5
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

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
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
GS110888551000048 [Primary]
GS180888551000047 [Unit of Use]

FDA Product Code

GDZHANDLE, SCALPEL

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


[10888551000048]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-11-06
Device Publish Date2019-08-13

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
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

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