FDA.reportPublic FDA data

Ultem Koh Cup

Primary DI
20888937015724
Brand
Ultem Koh Cup
Company
Coopersurgical, Inc.
Model
KCP-40-2
Device description
Ultem Koh Cup Non- Conductive - Vaginal Fornices Delineator 4.0 cm
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HEWCuldoscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEWCuldoscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937015724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088893701572420888937015724

GMDN Terms#

Term, Definition table
TermDefinition
Uterine manipulator cervical cup/transilluminatorA sterile distal component of a uterine manipulator designed to fit over the portio vaginalis to: 1) allow manipulation of the uterus under suction whilst preventing laparoscopic insufflation gas from escaping from the cervix (during hysterectomy); and 2) direct light from an independent light source for transillumination of the uterus/cervix (especially the posterior vaginal fornix) from a laparoscopic view point (through the diaphanoscopy effect). It consists of a small plastic cap. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceAPPLIED MEDICAL RESOURCES CORPORATIONHEW2026-04-22
19349967004996ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
19349967005009ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
29349967004993ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
29349967005006ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
10607915145313GelPOINT V-PathAPPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915145320GelPOINT V-PathAPPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915145337GelPOINT V-PathAPPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915146693GelPOINT V-PathAPPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
00607915145613GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-02-17
00888937015737Koh CupCoopersurgical, Inc.HEW2022-12-01
00888937015744Koh CupCoopersurgical, Inc.HEW2022-12-01
00888937015751Koh CupCoopersurgical, Inc.HEW2022-12-01
20888937015700Ultem Koh Cup Coopersurgical, Inc.HEW2022-12-01
20888937015717Ultem Koh Cup Coopersurgical, Inc.HEW2022-12-01
00888937015065RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015072RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015089RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015096RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015102RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015119RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015126RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015133RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015140Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015157Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015164Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015171Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015188Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015195Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015201Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10