FDA.reportPublic FDA data

Integra® Miltex® HeliMend® Advanced

Primary DI
10381780038528
Brand
Integra® Miltex® HeliMend® Advanced
Company
Integra Lifesciences Corporation
Model
62-207
Catalog number
62207
Device description
Integra® Miltex® HeliMend® Advanced Absorbable Collagen Membrane 20mm x 30mm
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYCBone grafting material, synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992216000BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANEIntegra Lifesciences Corp.1999-07-26LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780038522PackageGS112In Commercial Distribution
10381780038528PrimaryGS10
M269622071SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178003852230381780038522
1038178003852810381780038528

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial soft-tissue biomatrix implant, animal-derivedA bioabsorbable animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, through promotion of new blood vessels and/or by providing a temporary scaffold for tissue ingrowth; it is indicated for various oral soft tissue augmentation procedures (e.g., alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). It is a pliable material which may be fixed to soft tissues with sutures; it is applied to soft tissue during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Length30Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The product should be stored at room temperature. Avoid excessive heat and humidity.

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
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10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

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