FDA.reportPublic FDA data

Advincula Delineator™ Uterine Manipulator with 4.0 cm Ultem® Koh-Efficient®

Primary DI
00888937012767
Brand
Advincula Delineator™ Uterine Manipulator with 4.0 cm Ultem® Koh-Efficient®
Company
Coopersurgical, Inc.
Model
AD750-KE40
Device description
Advincula Delineator™ Uterine Manipulator with 4.0 cm Ultem® Koh-Efficient®
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
20888937012761PackageGS13In Commercial Distribution
00888937012767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701276120888937012761
00888937012767008889370127678889370127670888937012767

GMDN Terms#

Term, Definition table
TermDefinition
Uterine manipulator, single-useA sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

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-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915145320GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915145337GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915146693GelPOINT V-Path APPLIED 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
20888937015724Ultem 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