FDA.reportPublic FDA data

Porges Coloplast

Primary DI
05708932730181
Brand
Porges Coloplast
Company
Coloplast A/S
Model
RAC022
Catalog number
RAC022
Device description
Chiba puncture needles percutaneous nephrostomy set, 22G (ø 0.7 mm), 20 cm, Stainless steel
Published
2020-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBOCATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBOCatheter, Nephrostomy, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932730198PackageGS15In Commercial Distribution
05708932730181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932730198057089327301985708932730198
05708932730181057089327301815708932730181

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy catheter introduction needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access the kidney during nephrostomy catheter introduction for urinary drainage. It is intended to enable introduction of a guidewire (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. It may include an intraluminal stylet intended to add rigidity to the needle during introduction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Centimeter
Needle Gauge22Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from light in a cool and dry place

Contacts#

Phone, Email table
PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Company table
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