FDA.reportPublic FDA data

Urology Set

Primary DI
00860936000365
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIGInsufflator, Hysteroscopic
HRXArthroscope
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2
HRXArthroscopeOrthopedic2
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

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

Contacts#

Phone, Email table
PhoneEmail
1.888.542.9277aturner@thermedx.com

Regulatory Flags#

DUNS number
022465035
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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
20860936000369Urology SetLL0006LL00062018-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066524011683Arthroscope Ø 2.7 mm, 0°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011690Arthroscope Ø 2.7 mm, 30°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011706Arthroscope Ø 2.7 mm, 70°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011713HD3 Arthroscope Ø 4 mm, 0°,185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011720HD3 Arthroscope Ø 4 mm, 30°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011737HD3 Arthroscope Ø 4 mm, 45°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011744HD3 Arthroscope Ø 4 mm, 70°, 185 mm, autoclavableXION GmbHHRX2026-09-25
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