FDA.reportPublic FDA data

Urology Set

Primary DI
20860936000369
Brand
Urology Set
Company
THERMEDX, LLC
Model
LL0006
Catalog number
LL0006
Device description
Urology Set
Published
2018-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172048000FluidSmartThermedx, LLC2017-09-05HIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860936000369PackageGS110In Commercial Distribution
00860936000365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086093600036920860936000369
00860936000365008609360003658609360003650860936000365

GMDN Terms#

Term, Definition table
TermDefinition
Hysteroscopic irrigation/insufflation systemA mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure400millibar

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.888.542.9277aturner@thermedx.com

Regulatory Flags#

DUNS number
022465035
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00860936000341High Pressure Luer Lock Set, Single Lumen 300mmHgHLL0032016-09-23
00860936000334Luer Lock Set, Single LumenLL00022016-09-23
00860936000358Tubing Set - Single Lumen, Inflow with Dual OutflowLL00042016-09-23
00860936000365Urology SetLL0006LL00062018-02-01
00860936000310Fluid Management SystemP20002016-09-23
00860936000327Fluid Management SystemW21002016-09-23
20860936000338Luer Lock Set, Single LumenLL00022016-09-23
20860936000345High Pressure Luer Lock Set, Single Lumen 300mmHgHLL0032016-09-23
20860936000352Tubing Set - Single Lumen, Inflow with Dual OutflowLL00042016-09-23

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