FDA.reportPublic FDA data

Porges Coloplast

Primary DI
03600040184004
Brand
Porges Coloplast
Company
Coloplast A/S
Model
AE1138
Catalog number
AE1138
Device description
Seldinger PTFE-coated guidewire/J-Tip/stiff fixed core, length 80 cm
Published
2019-06-30
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
OCYEndoscopic guidewire, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCYEndoscopic Guidewire, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03600040184004PackageGS15In Commercial Distribution
03600040183991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040184004036000401840043600040184004
03600040183991036000401839913600040183991

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length80Centimeter
Outer Diameter0.038Inch

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

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Primary DI, Brand, Company table
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04262494460630N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460647N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494462528N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494463969N/ADoppkon GmbH & Co. KGOCY2025-09-12
54953170465050VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465067VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465074VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465081VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465098VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465104VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465111VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465128VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465135VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465142VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465159VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465166VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465173VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465180VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465197VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465203VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
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16976055232998Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24