AccessGUDID - DEVICE: Integra® Miltex® Helimend® (10381780038504)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex® Helimend®
Version or Model: 62205
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 62205
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780038504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58740	Dental/maxillofacial soft-tissue biomatrix implant, animal-derived	A 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYC	Bone grafting material, synthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: The product should be stored at room temperature. Avoid excessive heat and humidity.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 30 mm x 40 mm

Device Record Status

Public Device Record Key: b47b3754-73ab-415f-b59f-93b3ebfd01f3
Public Version Date: December 18, 2023
Public Version Number: 11
DI Record Publish Date: September 22, 2015