FDA.reportPublic FDA data

bio-ConneKt Fenestrated

Primary DI
00850026798128
Brand
bio-ConneKt Fenestrated
Company
Mlm Biologics, Inc.
Model
PN-50108
Catalog number
1101-FN33
Published
2025-08-01
Public version status
New
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
00850026798128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026798128008500267981288500267981280850026798128

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013117504DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00860013117511DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00850016008190BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008206BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008220BaseMEMViscus Biologics LLCKGN2026-09-21
05694310969468MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969482MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969505MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969529MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969543SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969567SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969581SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969604SurgiClose® CompactKERECIS hf.KGN2026-09-18
00841277111262Novera RenewHarps USA, Inc.KGN2026-08-26
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
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00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632618OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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