FDA.reportPublic FDA data

keramatrix

Manufacturer
Molecular Biologicals, LLC
Effective date
2019-03-18
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:49:15

Label at a glance#

Productkeramatrix
Active ingredientAMINO ACIDS, HAIR KERATIN
Label structure10 sections

Dosage and administration

NOTE: ALWAYS HANDLE USING ASEPTIC TECHNIQUE WOUND BED PREPARATION & APPLICATION MATRIX CHANGES AND REAPPLICATIONS Prepare wound area using standard debridement methods to ensure the wound is free of debris and devitalized tissue. The wound may be surgically debrided to ensure the wound edges contain viable tissue. Cut the dry keramatrix ® sheet into a piece slightly larger than the outline of the wound area. If th...

Storage and handling

Do not use if pouch has been opened or damaged. Should be stored at a clean, dry location at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Wound Matrix

Rx Prescription Only
Single Use

STERILER

C E
0 1 2 3

CAUTION

SPL UNCLASSIFIED SECTION

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician(or properly licensed Healthcare practitioner).

INDICATIONS FOR USE

INDICATIONS & USAGE SECTION

Acute surgical wounds, donor sites/grafts, podiatric wounds, wound dehiscence, diabetic ulcers, traumatic wounds, first & second degree Burns, chronic vascular ulcers, venous ulcers, Pressure ulcers, partial & full thickness wounds.

SUGGESTED DIRECTIONS FOR USE

DOSAGE & ADMINISTRATION SECTION

NOTE: ALWAYS HANDLE USING ASEPTIC TECHNIQUE

WOUND BED PREPARATION & APPLICATIONMATRIX CHANGES AND REAPPLICATIONS
  1. Prepare wound area using standard debridement methods to ensure the wound is free of debris and devitalized tissue. The wound may be surgically debrided to ensure the wound edges contain viable tissue.
  2. Cut the dry keramatrix® sheet into a piece slightly larger than the outline of the wound area. If the wound is larger than a single sheet then multiple sheets may be used,overlapping edges as necessary.
  3. For a wound with a low-level of exudate hydrate the matrix by soaking it in sterile saline solution for 2 minutes prior to application.
  4. Place the edge of the sheet in contact with intact tissue and smooth the matrix so that it contacts the underlying wound bed. If multiple matrices are used, overlap adjoining sheets to provide coverage of the entire wound. Secure with the preferred method of fixation[steri-strips, sutures, staples, clips}.
  5. After application use an appropriate, non-adherent, occlusive secondary dressing to maintain a moist environment. Ensure the matrix is well restrained.
  • Change keramatrix® sheet as necessary every 4 to 5 days days or as determined by the healthcare provider. Do not remove existing gel or matrix areas. The matrix will caramelize into a gel and have a off white light brown color.
  • Once cleansed with Sterile Saline solution keramatrix may be reapplied. Ensure that there are no bleeding areas and that the wound edges are clean.
  • For a wound with a medium to high level of exudate, place the edge of the sheet in contact with intact tissue and smooth the so that it contacts the underlying wound bed. Small openings can be cut into the sheet prior to application to allow adequate drainage and ensure tissue matrix contact with the wound bed.
  • Carefully document healing progression using customary healing parameters. Proceed with reapplication of appropriate non-adherent occlusive secondary dressing and maintain a moist environment.
  • If infection, excessive redness, blistering or allergic reaction occurs the matrix material should be removed.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Any known sensitivity to keratin.

PRECAUTIONS

PRECAUTIONS SECTION

Do not reuse or re-sterilize. Do not use if package is open or unsealed. Use prior to expiration date.

STORAGE

STORAGE AND HANDLING SECTION

Do not use if pouch has been opened or damaged. Should be stored at a clean, dry location at room temperature.

HOW SUPPLIED

HOW SUPPLIED SECTION

keramatrix is supplied in a clear pouch with labelled unit cartons.

keramatrix 5cm ×5cm Individual unit71474-303-05
keramatrix 5cm × 5cm Box of 5 units71474-303-55
keramatrix 5cm × 5cm Box of 10 units71474-303-51
keramatrix 10cm × 10cm Individual unit71474-303-01
keramatrix 10cm × 10cm Box of 5 units71474-303-50
keramatrix 10cm × 10cm Box of 10 units71474-303-10

SPL UNCLASSIFIED SECTION

Manufactured for:
Molecular Biologicals, LLC
Pasadena, TX 77505 | 1-844-793-9933
By Keraplast Research Limited
Gerald St, Lincoln 7674 NZ

PRINCIPAL DISPLAY PANEL - 5 Matrix Package Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For Wounds & Burns
Keramatrix®
Enriched With Bioactive Keratin

5x 5 Matrices
NDC 71474-303-50
10cm x 10cm (4" x 4")

LOT EXP1220G3

2020-12-31

CE
0123
STERILE R

Rx Only

replicine™

For Topical Use Only
Store in dry conditions between 0°
and 35°C (32° and 95° F).
Do not use if the packaging has been
damaged prior to use.
Sterility is guaranteed until the packaging
is first opened or damaged prior to use.
Do not reuse or resterilize.
See package insert for usage and
complete Prescribing Information.

MolecularBiologicals.com

MOLECULAR BIOLOGICALS

THE HEALING POWER OF NATURE

Manufactured for:
Molecular Biologicals, LLC
Pasadena, TX 77505

Manufactured by:
Keraplast Research Limited
Gerald St.
Lincoln, 7674
New Zealand (NZL)

PRINCIPAL DISPLAY PANEL - 5 Matrix Package Box Label
PRINCIPAL DISPLAY PANEL - 5 Matrix Package Box Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71474-303-01keramatrix1 in 1 POUCHNOT APPLICABLE13
71474-303-01keramatrix1 in 1 PACKAGENOT APPLICABLE13
71474-303-05keramatrix1 in 1 POUCHNOT APPLICABLE13
71474-303-05keramatrix1 in 1 PACKAGENOT APPLICABLE13
71474-303-10keramatrix10 in 1 PACKAGENOT APPLICABLE103
71474-303-10keramatrix10 in 1 BOXNOT APPLICABLE103
71474-303-50keramatrix5 in 1 BOXNOT APPLICABLE53
71474-303-50keramatrix5 in 1 PACKAGENOT APPLICABLE53
71474-303-51keramatrix10 in 1 BOXNOT APPLICABLE103
71474-303-51keramatrix10 in 1 PACKAGENOT APPLICABLE103
71474-303-55keramatrix5 in 1 PACKAGENOT APPLICABLE53
71474-303-55keramatrix5 in 1 BOXNOT APPLICABLE53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71474-303KERAMATRIX (AMINO ACIDS, HAIR KERATIN) NOT APPLICABLE [MOLECULAR BIOLOGICALS, LLC]312 package rows20190319_2a20cd23-bdcc-453e-a72c-de7c123b3db8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71474-303-01EA - Each71474-303657fb0ba-09f4-4941-95bc-ee18139ad11a12017-08-11
71474-303-05EA - Each71474-303ea015f6e-0fd9-46f1-bc25-162d33d45d3912017-08-11
71474-303-10EA - Each71474-30358674a60-8489-4e25-b8d0-ef077d9d228112017-08-11
71474-303-50EA - Each71474-30352fbb997-6d15-43fc-94d0-8d28bfa02b6b12017-08-11
71474-303-51EA - Each71474-303f1efb25a-a659-4ffa-96ce-0c91e4d0154512017-08-11
71474-303-55EA - Each71474-303f759cf5d-a717-429e-9b4e-ffd97c8ca4b912017-08-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71474-30371474-303-01, 71474-303-50, 71474-303-10, 71474-303-05, 71474-303-55, 71474-303-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMINO ACIDS, HAIR KERATING46579QK1MACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.