FDA.reportPublic FDA data

bio-ConneKt

Primary DI
00861175000109
Brand
bio-ConneKt
Company
Mlm Biologics, Inc.
Model
PN-50-100
Catalog number
1101-0505
Published
2023-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140456000BIO-CONNEKT WOUND MATRIXMLM Biologics, Inc.2014-07-22KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861175000109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861175000109008611750001098611750001090861175000109

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012813746
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026798111bio-ConneKt FenestratedPN-501071101-FN552025-08-01
00850026798128bio-ConneKt FenestratedPN-501081101-FN332025-08-01
00850026798135bio-ConneKtPN-501061101-16162025-08-01
00850026798142bio-ConneKtPN-501051101-15152025-08-01
00850026798159bio-ConneKtPN-501041101-04042025-08-01
00850026798166bio-ConneKtPN-50103A1101-01262025-08-01
00850026798173bio-ConneKtPN-501031101-06072025-08-01
00850026798180bio-ConneKtPN-501021101-02022025-08-01
00850026798197bio-ConneKtPN-501011101-03032025-08-01
00850026798203bio-ConneKtPN-501001101-05052025-08-01
00850026798210bio-ConneKt Mini-GraftPN-502021101-MG212025-08-01
00850026798227bio-ConneKt Mini-GraftPN-502001101-MG062025-08-01
00850026798234OrthoNovis ConnectPN-50104ONBNK-0442025-08-01
00850026798241OrthoNovis ConnectPN-50103ONBNK-0672025-08-01
00850026798258OrthoNovis ConnectPN-50102ONBNK-0222025-08-01
00850026798265OrthoNovis ConnectPN-50101ONBNK-0332025-08-01
00850026798272OrthoNovis ConnectPN-50100ONBNK-0552025-08-01
00850026798098bio-ConneKt FenestratedPN-53-1001101-FN552024-12-20
00850026798104bio-ConneKt FenestratedPN-53-1011101-FN332024-12-20
00850026798074bio-ConneKt Mini-GraftPN-52-1001101-MG062024-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028873PuraKOTE+COLLAGEN MATRIX, INC.KGN2026-05-26
00813954028880PuraPLUG+COLLAGEN MATRIX, INC.KGN2026-05-26
00813954028897PuraTAPE+COLLAGEN MATRIX, INC.KGN2026-05-26
10885632434303HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-05-22
00812593023010Agilon Surgical Collagen+Biogennix, LLCKGN2026-03-24
00812593023027Agilon Surgical Collagen+Biogennix, LLCKGN2026-03-24
30888277720729MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
20888277720739MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
10813954028436Tissue Specialists Resorbable Collagen PlugCOLLAGEN MATRIX, INC.KGN2026-03-09
10813954028443Tissue Specialists Resorbable Collagen TapeCOLLAGEN MATRIX, INC.KGN2026-03-09
10813954028559bioPLUGCOLLAGEN MATRIX, INC.KGN2026-03-09
10381780545569PriMatrix®INTEGRA LIFESCIENCESKGN2026-03-04
00861092002637Cealogic RibbonRECIBIO, INC.KGN2026-03-01
00854780005515Architect FxHARBOR MEDTECH, INC.KGN2026-02-25
00813909013589Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013596Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013602Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013619Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013657Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013664Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013671Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013695Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00008140135941SimpuritySAFE N' SIMPLE LLCKGN2026-02-10
08600103725002ReyaGelSTEMSYS LLCKGN2026-02-02
05694310968003Kerecis MariGen®KERECIS hf.KGN2026-01-30
05694310968027Kerecis MariGen®KERECIS hf.KGN2026-01-30
05694310968041Kerecis MariGen®KERECIS hf.KGN2026-01-30
05694310968065Kerecis MariGen®KERECIS hf.KGN2026-01-30
05694310968089Kerecis MariGen®KERECIS hf.KGN2026-01-30
05694310968102Kerecis MariGen®KERECIS hf.KGN2026-01-30