FDA.report

Biosoft

Primary DI
05701780336703
Brand
Biosoft
Company
Coloplast A/S
Model
BCAF75
Catalog number
BCAF75
Published
2024-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
05701780336703PackageGS11In Commercial Distribution
05701780337021PackageGS134In Commercial Distribution
05701780336598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05701780336703057017803367035701780336703
05701780337021057017803370215701780337021
05701780336598057017803365985701780336598

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 Gauge7French
Length28Centimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.

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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03600040963876ColoplastAC5904AC59042026-01-30
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03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
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03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

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