FDA.report

OrthoNovis Connect

Primary DI
00850026798265
Brand
OrthoNovis Connect
Company
Mlm Biologics, Inc.
Model
PN-50101ON
Catalog number
BNK-033
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

Related Records

Product Codes

CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications

CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions

SubmissionSupplement
K140456000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850026798265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026798265008500267982658500267982650850026798265

GMDN Terms

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

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 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
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

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10813954028559bioPLUGCOLLAGEN MATRIX, INC.KGN2026-03-09
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