FDA.reportPublic FDA data

ContourMD

Primary DI
00840425320747
Brand
ContourMD
Company
ContourMD Marketing Group, LLC
Model
LIPO-10
Published
2024-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840425320747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840425320747008404253207478404253207470840425320747

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
913-541-9200customerservice@contourmd.com

Regulatory Flags#

DUNS number
147299259
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840425320662ContourMDLIP-01LIP-012024-08-01
00840425320679ContourMDLIP-01-ABBDLIP-01-ABBD2024-08-01
00840425320686ContourMDLIP-01-NBLIP-01-NB2024-08-01
00840425320693ContourMDLIP-02LIP-022024-08-01
00840425320716ContourMDLIP-03LIP-032024-08-01
00840425320723ContourMDLIP-03-BBLLIP-03-BBL2024-08-01
00840425320754ContourMDPurchased: LIP-02-BBLPurchased: LIP-02-BBL2024-08-01
00840425320792ContourMDPurchased:CMD-LUMBB-0SPurchased:CMD-LUMBB-0S2024-08-01

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Primary DI, Brand, Company table
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