FDA.reportPublic FDA data

Dormia

Primary DI
03600040955543
Brand
Dormia
Company
Coloplast A/S
Model
EXN734
Catalog number
EXN734
Published
2024-04-05
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
FFLDISLODGER, STONE, BASKET, URETERAL, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFLDislodger, Stone, Basket, Ureteral, MetalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03600040955536PackageGS11In Commercial Distribution
03600040955543PackageGS19In Commercial Distribution
03600040955529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040955536036000409555363600040955536
03600040955543036000409555433600040955543
03600040955529036000409555293600040955529

GMDN Terms#

Term, Definition table
TermDefinition
Urinary stone retrieval basket, single-useA manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate urinary stones for the treatment of conditions such as nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is used with a nephroscope or ureteroscope during urological and related procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge2.2French
Device Size Text, specify0
Length120Centimeter

Storage And Handling#

Type, Low, High table
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 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
14953170458368DISPOSABLE GRASPING FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.FFL2025-05-14
00810143891300Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFL2025-04-25
00810143891317Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFL2025-04-25
B0325550200HaloSACRED HEART MEDICAL,INC.FFL2024-07-18
03600040955482DormiaColoplast A/SFFL2024-04-05
03600040955598DormiaColoplast A/SFFL2024-04-05
03600040955659Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955727Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955758Dormia N.StoneColoplast A/SFFL2024-04-05
06936534320465Single Use Urinary Stone Retrieval BasketZhejiang Chuangxiang Medical Technology Co., LTD.FFL2023-10-24
16936881136815Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881136822Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881139380Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881139397Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881150095Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881150101Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16944932724331Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
04055207023273NARichard Wolf GmbHFFL2023-06-20
06971381251647Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
16971381251651Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
16971381251668Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
16971381251675Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
03600040326824Dormia DualPercColoplast A/SFFL2023-03-14
03600040326855Dormia DualPercColoplast A/SFFL2023-03-14
04055207018439NARichard Wolf GmbHFFL2022-08-09
04055207023495NARichard Wolf GmbHFFL2022-08-09
B937DOF1511Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23
B937DOF1581Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23
B937DOF2011Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23
B937DOF2081Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23