FDA.report

Exam Gown, 3 ply

Primary DI
00616784811628
Brand
Exam Gown, 3 ply
Company
DYNAREX CORPORATION
Model
8116
Device description
Exam Gown, 3-ply tissue, White
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
00616784811635PrimaryGS10
00616784811628Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784811635006167848116356167848116350616784811635
00616784811628006167848116286167848116280616784811628

GMDN Terms

TermDefinition
Patient gown, single-useA non-sterile garment made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and may be closed by ties at the back/side of the garment. This is a single-use garment.

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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