PDS PDP451H

GUDID 10705031048324

Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture

ETHICON, LLC

Polyester suture, bioabsorbable, monofilament, antimicrobial

Primary Device ID	10705031048324
NIH Device Record Key	9968b486-d430-4e6e-a344-7dc32f59916c
Commercial Distribution Status	In Commercial Distribution
Brand Name	PDS
Version Model Number	PDP451H
Catalog Number	PDP451H
Company DUNS	079402290
Company Name	ETHICON, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx
Phone	+1(877)384-4266
Email	xxx@xxx.xxx

Operating and Storage Conditions

Storage Environment Temperature	Between 0 and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 30 Degrees Celsius
Storage Environment Temperature	Between 0 and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 30 Degrees Celsius
Storage Environment Temperature	Between 0 and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 30 Degrees Celsius
Storage Environment Temperature	Between 0 and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 30 Degrees Celsius
Storage Environment Temperature	Between 0 and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 30 Degrees Celsius
Storage Environment Temperature	Between 0 and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 30 Degrees Celsius
Storage Environment Temperature	Between 0 and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031048324 [Primary]
GS1	30705031048328 [Package] Package: BOX [36 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K061037

FDA Product Code

NEW	SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2021-02-05
Device Publish Date	2015-09-01

On-Brand Devices [PDS]

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