FDA.report

MEDLINE

Primary DI
40080196036616
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYND70822
Catalog number
DYND70822
Device description
SHV PREP TRAY FXD. RZ 1 COMPAR
Published
2022-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OJUSkin prep tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJUSkin Prep TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196036616PackageGS150In Commercial Distribution
10080196036615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019603661640080196036616
1008019603661510080196036615

GMDN Terms

TermDefinition
Surgical patient preparation kitA collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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