PDS PDP513G

GUDID 10705031048485

Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture

ETHICON, LLC

Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial Polyester suture, bioabsorbable, monofilament, antimicrobial
Primary Device ID10705031048485
NIH Device Record Key21e52c5c-2be1-40ba-8656-359a08562f50
Commercial Distribution StatusIn Commercial Distribution
Brand NamePDS
Version Model NumberPDP513G
Catalog NumberPDP513G
Company DUNS079402290
Company NameETHICON, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110705031048485 [Primary]
GS130705031048489 [Package]
Package: BOX [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-11
Device Publish Date2015-09-01

On-Brand Devices [PDS]

20705031206905Violet Monofilament (Polydioxanone), Synthetic Absorbable Surgical Suture
10705031048690Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031048485Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031048447Antibacterial Clear Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031048430Antibacterial Clear Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031048416Antibacterial Clear Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031048379Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031048355Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031048249Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031048164Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031048089Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031047969Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031047884Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031047877Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
10705031047860Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
30705031239399Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031233225Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
30705031231034Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
30705031231010Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031203488Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031203389Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031203334Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031134492Clear Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031134393Clear Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031134386Clear Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031134379Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031134331Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031134324Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031134317Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031134294Violet Monofilament (Polydioxanone), Synthetic Absorbable Suture
10705031062108Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031062078Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031062061Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031062054Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031062047Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031062030Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031062023Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
30705031062010Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061996Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061989Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061965Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061941Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061934Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061927Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061903Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061897Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061880Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061866Clear Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061842Clear Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture
10705031061804Clear Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture

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