FDA.report

Disposable Scrub Shirt, V-Neck

Primary DI
00616784195834
Brand
Disposable Scrub Shirt, V-Neck
Company
DYNAREX CORPORATION
Model
1958
Device description
Disposable Scrub Shirt, V-Neck, X-Large, Light Blue
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications

CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784195834PackageGS130In Commercial Distribution
00616784195827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784195834006167841958346167841958340616784195834
00616784195827006167841958276167841958270616784195827

GMDN Terms

TermDefinition
Scrub suit, single-useA two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
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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