HeliCote ® ABSORBABLE COLLAGEN Wound Dressing For Dental Surgery 62-201

GUDID 30381780000291

HeliCote ® ABSORBABLE COLLAGEN Wound Dressing, 3/4in x 1 1/2in

Integra Lifesciences Corporation

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived

Primary Device ID	30381780000291
NIH Device Record Key	e702f0b3-76e8-4b5e-a4a0-996260c068a3
Commercial Distribution Status	In Commercial Distribution
Brand Name	HeliCote ® ABSORBABLE COLLAGEN Wound Dressing For Dental Surgery
Version Model Number	62-201
Catalog Number	62-201
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
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
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
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com
Phone	+1(800)654-2873
Email	custsvcnj@integralife.com

Device Dimensions

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Operating and Storage Conditions

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

Device Issuing Agency	Device ID
GS1	00381780000290 [Unit of Use]
GS1	10381780000297 [Primary]
GS1	30381780000291 [Package] Contains: 10381780000297 Package: Case [4 Units] In Commercial Distribution
HIBCC	H834622011 [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

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M2483223P1 - Omni-Tract®	2024-04-05 Fence Swivel Blade with 3/8in (1.0cm) Hole, 4in x 5in (10.2cm x 12.7cm)
M268S438A1200B1 - BUDDE®	2024-04-05 SAMY™ Vascular Retractor Blade – Long 4.6"
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Trademark Results [HeliCote]

Mark Image Registration \| Serial	Company Trademark Application Date
HELICOTE 77327931 3581431 Live/Registered	Integra LifeSciences Corporation 2007-11-13
HELICOTE 73453238 1311950 Dead/Cancelled	Helitrex, Inc. 1983-11-17