FDA.reportPublic FDA data

N/A

Primary DI
00889024578685
Brand
N/A
Company
DORNOCH MEDICAL SYSTEMS, INC.
Model
UL-ST100
Catalog number
UL-ST100
Device description
Specimen Trap - 10/case
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024578685PrimaryGS10
70889024578684Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024578685008890245786858890245786850889024578685
7088902457868470889024578684

GMDN Terms#

Term, Definition table
TermDefinition
Surgical fluid/smoke waste management system suction unitA mobile, mains electricity (AC-powered) device assembly designed to collect surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a suction pump, tubing, collection containers, a vacuum gauge, a vacuum control knob, an overflow trap, and a special filter for smoke evacuation. It uses negative pressure (suction) at the site of intervention to collect fluid in its collection containers and filter captured smoke with its filters. It is attached to a dedicated disposal unit for automatic container emptying and cleaning to prepare for the next use.

Contacts#

Phone, Email table
PhoneEmail
1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
004687018
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024355552Fluid Waste Management - ConsumablesTP-RS800TP-RS8002020-03-16
00889024465923UltrafleX QuadUL-QD500SEUL-QD500SE2016-09-23
00889024465909UltrafleX QuadUL-QD500UL-QD5002018-01-10
00889024578647N/ATP-CYSTOTP-CYSTO2021-11-16
00889024355545N/ATP-RS400TP-RS4002020-09-23
00889024465961NATPDC1800TP-DC18002017-06-09
00889024465978NATPDCL2800TP-DCL28002017-06-09
00889024465947N/ATPRC1800TP-RC18002016-09-21
00889024465954N/ATPRC2800TP-RC28002016-09-21
00889024578654N/ATP-SOC600TP-SOC6002021-11-16
00889024578661N/ATP-SOC650TP-SOC6502021-11-16
00889024578678N/ATP-SOC650ETP-SOC650E2021-11-16
70889024578646N/ATP-CYSTOTP-CYSTO2021-11-16
70889024578653N/ATP-SOC600TP-SOC6002021-11-16
70889024578660N/ATP-SOC650TP-SOC6502021-11-16
70889024578677N/ATP-SOC650ETP-SOC650E2021-11-16
00846795008599Stablecut®9640040002017-02-17
70889024578684N/AUL-ST100UL-ST1002020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956231788CARDINAL HEALTHCardinal Health 200, LLCGCY2025-10-20
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
50192253042748ArgyleCardinal Health 200, LLCGCY2025-10-02
50192253042755ArgyleCardinal Health 200, LLCGCY2025-10-02
10198956012769CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
10197106675588CARDINAL HEALTHCardinal Health 200, LLCGCY2024-05-22
10197106600788CARDINAL HEALTHCardinal Health 200, LLCGCY2024-03-25
00630094061504Bioseal Inc.BIOSEALGCY2024-01-29
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00630094049175Bioseal Inc.BIOSEALGCY2024-01-25
10197106520932CARDINAL HEALTHCardinal Health 200, LLCGCY2024-01-24
00630094049052Bioseal Inc.BIOSEALGCY2024-01-24
00630094049168Bioseal Inc.BIOSEALGCY2024-01-24
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