FDA.reportPublic FDA data

Porges Coloplast

Primary DI
05708932730198
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
OTC
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
305524696
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
25051684011584Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011591Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011607Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011614Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011621Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011638Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011645Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011652Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011669Total AbscessionAngiodynamics, Inc.GBO2024-10-30
04046955638406ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638581ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638604ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638741ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638789ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638840ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638888ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638963ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638987ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639007ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639021ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639045ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639083ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639106ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639120ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639144ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639182ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639205ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
10812261012282allDrainALLWIN MEDICAL DEVICES, INC.GBO2023-07-28
16936881156561Nephrostomy introduction Needle Diamond TipWell Lead Medical Co.,LtdGBO2022-12-08
16936881156578Nephrostomy introduction Needle Diamond TipWell Lead Medical Co.,LtdGBO2022-12-08