FDA.report

Medline

Primary DI
40080196915058
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJP2000A
Catalog number
DYNJP2000A
Device description
GOWN,SURGICAL,AURORA,SLEEVE
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FYAGOWN, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196915058PackageGS160In Commercial Distribution
10080196915057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019691505840080196915058
1008019691505710080196915057

GMDN Terms

TermDefinition
Surgical sleeve coverA forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Avoid contact with an open flame or high intensity heat source

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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