Integra Miltex Helimend Absorbable Collagen Membrane 62204

GUDID 30381780038492

HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendon. These collagen products provide wound stabilization and create space during guided tissue regeneration procedures where a longer absorption rate is desired. HeliMEND Advanced collagen membrane is absorbed within 18 weeks.

Integra Lifesciences Corporation

General oral wound dressing, animal-derived
Primary Device ID30381780038492
NIH Device Record Keyd22dc189-4ac6-4fdd-8838-df614afd7bf5
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegra Miltex Helimend Absorbable Collagen Membrane
Version Model Number62204
Catalog Number62204
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
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 Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780038498 [Primary]
GS130381780038492 [Package]
Contains: 10381780038498
Package: CAS [12 Units]
In Commercial Distribution
HIBCCM269622041 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYCBone grafting material, synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

[30381780038492]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-07
Device Publish Date2015-09-22

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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)
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