FDA.report

VALVE XS

Primary DI
04046963756987
Brand
VALVE XS
Company
Aesculap AG
Model
FC360R
Catalog number
FC360R
Device description
VALVE XS Atrium Retractor, complete set, consisting of FC361R, FC362R, FC363R, FC364R, FC365R, FC366R, FC367R, non-sterile, reusable
Published
2020-04-24
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
false

Related Records

Contact Domains

Product Codes

CodeName
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046963756987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046963756987040469637569874046963756987

GMDN Terms

TermDefinition
General-purpose caseworkFurniture consisting of different units, e.g., cabinets, shelves, racks, worktops, combined and installed in a healthcare facility to provide users with a general-purpose functional work and storage place. This will also separate the floor/room area creating a practical discrete working environment for the staff. The units are used to store materials, supplies, devices, records, samples, and other items. This furniture is usually modular and constructed using thicker panels and more long-lasting surface finishes than ordinary office/domestic furniture.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false
Sterilization required before use
true

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