FDA.reportPublic FDA data

Fenestrated NeoDrape

Primary DI
10817584013374
Brand
Fenestrated NeoDrape
Company
NEOMED, INC.
Model
ND-FS
Catalog number
ND-FS
Device description
Fenestrated NeoDrape
Published
2020-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMEGown, Examination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817584013371PackageGS140In Commercial Distribution
10817584013374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081758401337120817584013371
1081758401337410817584013374

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Regulatory Flags#

DUNS number
799772079
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817584013336NeoDrapeNDND2020-05-19
00817584010147NeoMed Oral SyringeBA-S3EO-SBA-S3EO-S2016-09-19
00817584010161NeoMed Oral SyringeBA-S6EO-SBA-S6EO-S2016-09-19
00817584010178NeoMed Oral SyringeBA-S12EO-SBA-S12EO-S2016-09-19
00817584010222NeoBottleSSNB-CLSSNB-CL2016-09-19
00817584010239NeoBottleSSNB-AMSSNB-AM2016-09-19
00817584011038NeoConnect Oral Administration TipPOA-TNCPOA-TNC2016-09-19
00817584011113NeoBottlePSSNB-AMPSSNB-AM2016-09-19
00817584011120NeoBottlePSSNB-CLPSSNB-CL2016-09-19
00817584011205GravityProPNM-S100EOVPNM-S100EOV2016-09-19
00817584011212GravityProPNM-S20EOVPNM-S20EOV2016-09-19
00817584011274GravityProNM-S20EOVNM-S20EOV2016-09-19
00817584011281NeoMed Oral / Enteral SyringeNM-S60EONM-S60EO2016-09-19
00817584011298NeoMed Oral / Enteral SyringeNM-S35EONM-S35EO2016-09-19
00817584011304NeoMed Oral / Enteral SyringeNM-S20EONM-S20EO2016-09-19
00817584011311NeoMed Oral / Enteral SyringeNM-S12EONM-S12EO2016-09-19
00817584011328NeoMed Oral / Enteral SyringeNM-S6EONM-S6EO2016-09-19
00817584011335NeoMed Oral / Enteral SyringeNM-S3EONM-S3EO2016-09-19
00817584011342NeoMed Oral / Enteral SyringeNM-S1EONM-S1EO2016-09-19
00817584012097NeoConnect Oral / Enteral SyringePNM-S1NCPNM-S1NC2016-09-19

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Primary DI, Brand, Company table
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20612899005482EncompassEncompass Group, L.L.C.FME2023-06-21
20612899005499EncompassEncompass Group, L.L.C.FME2023-06-21