FDA.reportPublic FDA data

Advincula Delineator™ Uterine Manipulator with 2.5 cm Ultem® Koh-Efficient®

Primary DI
00888937013801
Brand
Advincula Delineator™ Uterine Manipulator with 2.5 cm Ultem® Koh-Efficient®
Company
Coopersurgical, Inc.
Model
AD750-KE25
Device description
Advincula Delineator™ Uterine Manipulator with 2.5 cm Ultem® Koh-Efficient®
Published
2016-10-24
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143650000CooperSurgical Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.2015-07-21HEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937013805PackageGS13In Commercial Distribution
00888937013801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701380520888937013805
00888937013801008889370138018889370138010888937013801

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.

Sterilization Methods#

Method table
Method

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
00888937027327ER-SpecC0203002026-08-05
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06
00888937027457ER-SpecC020130-12026-08-06
00888937027464ER-SpecC020140-12026-08-06
00888937027594AnoSPECC0601002026-08-05
00888937027600AnoSPECC0601102026-08-05
00888937027617AnoSPECC0601202026-08-05
00888937032833LifeGlobal® Coda®Incubator UnitGCIU-010-M2026-08-03
00888937032840LifeGlobal® Coda®Filter for Incubator UnitGCIF-001-M2026-08-03

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
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