4116

GUDID 10888551010313

KNIFE SET ECTRA II (PACK OF 3)

STERILMED, INC.

Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use Surgical saw blade, reciprocating, single-use
Primary Device ID10888551010313
NIH Device Record Key1dfd2eed-1768-4b1d-9a70-1e37811f0581
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDYO4116
Catalog Number4116
Company DUNS175899459
Company NameSTERILMED, INC.
Device Count3
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
GS110888551010313 [Primary]
GS180888551010312 [Unit of Use]

FDA Product Code

HTSKNIFE, ORTHOPEDIC

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


[10888551010313]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-01-22
Device Publish Date2019-08-13

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 - NA2021-01-22KNIFE SET ECTRA II (PACK OF 3)
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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