Medifil

Primary DI
00850048866188
Brand
Medifil
Company
Human Biosciences Inc.
Model
MF2001
Device description
Medifil sterile collagen particles, 1 gram vial
Published
2023-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOZBeads, Hydrophilic, For Wound Exudate Absorption

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOZBeads, Hydrophilic, For Wound Exudate AbsorptionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048866188PackageGS15In Commercial Distribution
00850048866126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048866188008500488661888500488661880850048866188
00850048866126008500488661268500488661260850048866126

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

Contacts#

Phone, Email table
PhoneEmail
301-740-1893info@humanbiosciences.com

Regulatory Flags#

DUNS number
014511541
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
00850048866928CelluhealCF20022025-11-17
00850048866966Collecule LpHCSP10012025-11-17
00850048866942SkinTemp IIST105102025-06-16
00850048866034CelluhealCS10222023-09-28
00850048866058MedifilMF20022023-06-19
00850048866089SkinTemp IIST10022023-06-19
00850048866096SkinTemp IIST10222023-06-19
00850048866102SkinTemp IIST10772023-06-19
00850048866119SkinTemp IIST10032023-06-19
00850048866126MedifilMF20012023-06-19
00850048866041CelluhealCF20012023-09-28
00850048866133CollatekCG10012023-06-19
00850048866959CelluhealCS105102025-06-16
00850048866300CelluhealCS10222023-09-28
00850048866195MedifilMF20022023-06-19
00850048866157SkinTemp IIST10022023-06-19
00850048866140SkinTemp IIST10222023-06-19
00850048866164SkinTemp IIST10772023-06-19
00850048866171SkinTemp IIST10032023-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850048866928CelluhealHuman Biosciences Inc.KOZ2025-11-17
00850048866966Collecule LpHHuman Biosciences Inc.KOZ2025-11-17
00850048866041CelluhealHuman Biosciences Inc.KOZ2023-09-28
00850048866058MedifilHuman Biosciences Inc.KOZ2023-06-19
00850048866126MedifilHuman Biosciences Inc.KOZ2023-06-19
00850048866195MedifilHuman Biosciences Inc.KOZ2023-06-19
00896005002435SimpuritySAFE N' SIMPLE LLCKOZ2021-11-30
00896005002442SimpuritySAFE N' SIMPLE LLCKOZ2021-11-30
06936943411150Huibo MedicalHenan Huibo Medical Co.,Ltd.KOZ2020-01-21
06936943411488Huibo MedicalHenan Huibo Medical Co.,Ltd.KOZ2020-01-21
00850004779750SimpuritySAFE N' SIMPLE LLCKOZ2019-08-12
00850004779774SimpuritySAFE N' SIMPLE LLCKOZ2019-08-12