ORAPLUG® Absorbable Collagen Wound Dressing for Dental Surgery #ORAPLUG-PKG-10

GUDID 30381780000321

SALVIN OraPLUG® Absorbable Collagen Wound Dressing, 3/8in x 3/4in

Integra Lifesciences Corporation

Collagen wound matrix dressing

Primary Device ID	30381780000321
NIH Device Record Key	55ddc8d2-7399-47ba-9d05-27a42aeefbe4
Commercial Distribution Status	In Commercial Distribution
Brand Name	ORAPLUG® Absorbable Collagen Wound Dressing for Dental Surgery
Version Model Number	#ORAPLUG-PKG-10
Catalog Number	#ORAPLUG-PKG-10
Company DUNS	083171244
Company Name	Integra Lifesciences Corporation
Device Count	10
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	false
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(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity
Special Storage Condition, Specify	Between 0 and 0 *Avoid excessive heat and humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381780000320 [Unit of Use]
GS1	10381780000327 [Primary]
GS1	30381780000321 [Package] Contains: 10381780000327 Package: Case [4 Units] In Commercial Distribution
HIBCC	M268ORAPLUGPKG101 [Secondary]

FDA Product Code

LPG	Material, Dressing, Surgical, Polylactic Acid

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	2020-05-06
Device Publish Date	2014-09-11

Devices Manufactured by Integra Lifesciences Corporation

10381780268536 - Omni-Tract®	2024-07-18 Omni-Tract® Arm, Fixed Angle, 8in x 12in (20.3cm x 30.5cm) x 75°
10381780269106 - Omni-Tract®	2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 3in (3.8cm x 7.6cm)
10381780269113 - Omni-Tract®	2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 4in (3.8cm x 10.2cm)
10381780538134 - Omni-Tract®	2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 5in (3.8cm x 12.7cm)
10381780538158 - Omni-Tract®	2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, .75in x 2in (1.9cm x 5.1cm)
10381780538165 - Omni-Tract®	2024-07-18 Omni-Tract® Malleable Swivel Retractor, 1in x 3in (2.5cm x 7.6cm) Mini
10381780538172 - Omni-Tract®	2024-07-18 Omni-Tract® Medial Retractor, 1.5in x 3.5in (3.8cm x 8.9cm)
10381780538189 - Omni-Tract®	2024-07-18 Omni-Tract® Meyerding Retractor, Blunt, 1in x 3in (2.5cm x 7.6cm)

Trademark Results [ORAPLUG]

Mark Image Registration \| Serial	Company Trademark Application Date
ORAPLUG 77544935 3710009 Live/Registered	Salvin Dental Specialties, Inc. 2008-08-12