epic edge

GUDID 00855019008024

10/0 BL Mono Nylon, 30 cm length, 1/2 cir Spatula Ndl, Double Arm (single device)

R.K. MANUFACTURING CORPORATION OF CONNECTICUT

Nylon suture, non-bioabsorbable, monofilament
Primary Device ID00855019008024
NIH Device Record Key4b5b54f0-87e5-476f-b4e7-5207114d2d73
Commercial Distribution StatusIn Commercial Distribution
Brand Nameepic edge
Version Model NumberN2626
Company DUNS116162108
Company NameR.K. MANUFACTURING CORPORATION OF CONNECTICUT
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-797-8700
Emailalabarre@rkmcorp.com
Phone203-797-8700
Emailalabarre@rkmcorp.com
Phone203-797-8700
Emailalabarre@rkmcorp.com
Phone203-797-8700
Emailalabarre@rkmcorp.com
Phone203-797-8700
Emailalabarre@rkmcorp.com
Phone203-797-8700
Emailalabarre@rkmcorp.com
Phone203-797-8700
Emailalabarre@rkmcorp.com
Phone203-797-8700
Emailalabarre@rkmcorp.com
Phone203-797-8700
Emailalabarre@rkmcorp.com
Phone203-797-8700
Emailalabarre@rkmcorp.com
Phone203-797-8700
Emailalabarre@rkmcorp.com
Phone203-797-8700
Emailalabarre@rkmcorp.com

Device Dimensions

Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100855019008024 [Primary]
GS110855019008021 [Package]
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

GARSuture, Nonabsorbable, Synthetic, Polyamide

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00855019008024]

Ethylene Oxide


[00855019008024]

Ethylene Oxide


[00855019008024]

Ethylene Oxide


[00855019008024]

Ethylene Oxide


[00855019008024]

Ethylene Oxide


[00855019008024]

Ethylene Oxide


[00855019008024]

Ethylene Oxide


[00855019008024]

Ethylene Oxide


[00855019008024]

Ethylene Oxide


[00855019008024]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-07
Device Publish Date2018-06-08

On-Brand Devices [epic edge]

0085501900803110/0 BL Mono Nylon, 30 cm length, 3/8 cir Spatula Ndl, Double Arm (single device)
0085501900802410/0 BL Mono Nylon, 30 cm length, 1/2 cir Spatula Ndl, Double Arm (single device)
0085501900801710/0 BL Mono Nylon, 10 cm length, 3/8 cir Spatula Ndl, Single Arm (single device)
0085501900800010/0 BL Mono Nylon, 10 cm length, 1/2 cir Spatula Ndl, Single Arm (single device)

Trademark Results [epic edge]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EPIC EDGE
EPIC EDGE
87129070 5330805 Live/Registered
TransAct Technologies Incorporated
2016-08-05
EPIC EDGE
EPIC EDGE
87126293 5137648 Live/Registered
Pacific Coast Building Products, Inc.
2016-08-03

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