FDA.report

Drape Sheets

Primary DI
00616784814124
Brand
Drape Sheets
Company
DYNAREX CORPORATION
Model
8141
Device description
Drape Sheets (White) 2 ply, Tissue, 40x72
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FMEGown, Examination

Product Code Classifications

CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784814131PrimaryGS10
00616784814124Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784814131006167848141316167848141310616784814131
00616784814124006167848141246167848141240616784814124

GMDN Terms

TermDefinition
Examination/treatment table paperA non-sterile sheet made of paper intended to cover the surface of an examination/treatment table, or chair, during use to function as a barrier between the table top and the patient to maintain hygienic conditions. It is typically supplied in a roll designed to be mounted at one end of the table such that a new length of paper can be pulled down over the table top for each new patient. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10842942015448PRIMEDpriMED Medical Products IncFME2026-02-10
00810180842457Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, UniversalDynarex CorporationFME2026-01-05
26975803530888GSOGroup Supply Organization Medical Technology(Shanghai) LtdFME2025-11-30
10842942017527PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
10842942017534PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
10842942007825PRIMEDpriMED Medical Products IncFME2025-07-21
10842942008204PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009348PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009355PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009362PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009379PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009553PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009560PRIMEDpriMED Medical Products IncFME2025-07-21
10842942013925PRIMEDpriMED Medical Products IncFME2025-07-21
10842942014472PRIMEDpriMED Medical Products IncFME2025-07-21
10842942014489PRIMEDpriMED Medical Products IncFME2025-07-21
10842942016087PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524427PRIMEDpriMED Medical Products IncFME2025-07-21
00840456201565JMUJMU DENTAL, INCFME2025-07-15
00840456201572JMUJMU DENTAL, INCFME2025-07-15
00840456201589JMUJMU DENTAL, INCFME2025-07-15
00840456201596JMUJMU DENTAL, INCFME2025-07-15
00840456201602JMUJMU DENTAL, INCFME2025-07-15
00840456201619JMUJMU DENTAL, INCFME2025-07-15
00840456201626JMUJMU DENTAL, INCFME2025-07-15
00840456201633JMUJMU DENTAL, INCFME2025-07-15
00840456201640JMUJMU DENTAL, INCFME2025-07-15
00840456201657JMUJMU DENTAL, INCFME2025-07-15
00840456201664JMUJMU DENTAL, INCFME2025-07-15
00840456201671JMUJMU DENTAL, INCFME2025-07-15