FDA.report

Novoflow

Primary DI
03600040988428
Brand
Novoflow
Company
Coloplast A/S
Model
BCCJ84
Catalog number
BCCJ84
Device description
Length 26 cm, Catheter Gauge 8 FR/CH.
Published
2022-11-14
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
FADStent, ureteral

Product Code Classifications

CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03600040988428PackageGS11In Commercial Distribution
03600040988435PackageGS119In Commercial Distribution
03600040988411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03600040988428036000409884283600040988428
03600040988435036000409884353600040988435
03600040988411036000409884113600040988411

GMDN Terms

TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge8French
Length26Centimeter
Outer Diameter0.11Inch
Outer Diameter2.7Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags

DUNS number
305524696
Device count
1
DM exempt
false
Premarket exempt
false
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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03600040966310ColoplastACP305ACP3052026-01-30

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