FDA.reportPublic FDA data

bio-ConneKt Mini-Graft

Primary DI
00850026798210
Brand
bio-ConneKt Mini-Graft
Company
Mlm Biologics, Inc.
Model
PN-50202
Catalog number
1101-MG21
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00850026798210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026798210008500267982108500267982100850026798210

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012813746
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00850026798081bio-ConneKt Mini-GraftPN-52-1021101-MG212024-06-21

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