FDA.report

MEDLINE

Primary DI
20193489111122
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MNS7605A
Catalog number
MNS7605A
Device description
BREAST BIOPSY KIT
Published
2021-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PXPBreast biopsy / localization tray

Product Code Classifications

CodeDeviceSpecialtyClass
PXPBreast Biopsy / Localization TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489111122PackageGS120In Commercial Distribution
10193489111125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348911112220193489111122
1019348911112510193489111125

GMDN Terms

TermDefinition
Soft-tissue biopsy procedure kit, medicatedA collection of sterile devices, which includes a pharmaceutical(s), designed to perform a non-specific soft tissue biopsy (e.g., skin biopsy, breast biopsy); it is not dedicated to biopsy of a specific internal organ. It includes the biopsy needle used for this procedure. 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
true
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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10197344039890MEDLINEHNY22100HNY221002024-10-11
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