FDA.report

Drape Sheets

Primary DI
00616784815022
Brand
Drape Sheets
Company
DYNAREX CORPORATION
Model
8150
Device description
Drape Sheets (Blue PMS 2727) Poly/tissue 2 ply 40x90
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
00616784815039PrimaryGS10
00616784815022Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784815039006167848150396167848150390616784815039
00616784815022006167848150226167848150220616784815022

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

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