FDA.reportPublic FDA data

Arch Koh-Efficient

Primary DI
20888937015205
Brand
Arch Koh-Efficient
Company
Coopersurgical, Inc.
Model
KCS-ARCH-35
Device description
Arch Koh-Efficient - 3.5 cm for use with the Advincula Arch Handle - Harmonic scalpel and laser
Published
2022-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20888937015205PackageGS15In Commercial Distribution
00888937015201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701520520888937015205
00888937015201008889370152018889370152010888937015201

GMDN Terms#

Term, Definition table
TermDefinition
Colpotomy tubeA sterile, hand-held, hollow cylindrical device designed to facilitate dissection of the cervical/vaginal junction during total laparoscopic-assisted hysterectomy. It is typically made of plastic material and functions as a transvaginal conduit for surgical instruments and as an anvil-like support during dissection. Its distal end is designed to fit tightly against the cervix, and its proximal end has a seal to prevent loss of peritoneum-distention gas [e.g., carbon dioxide (CO2)] used during the laparoscopic procedure. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60888937029798ORIGIO Gradient 90 w/o Gentamicin 84905060D2026-03-12
00888937028331ORIGIO Sequential Blast83050010M2026-02-05
00888937028348ORIGIO Sequential Blast83050060M2026-02-05
00888937028355ORIGIO Sequential Blast83060010M2026-02-05
00888937028386ORIGIO Sequential Cleav83030010M2026-02-05
00888937028393ORIGIO Sequential Cleav83030060M2026-02-05
00888937028409ORIGIO Sequential Cleav83040010M2026-02-05
00888937028416ORIGIO Sequential Cleav83040060M2026-02-05
00888937028430ORIGIO Sequential Fert83010010M2026-02-05
00888937028447ORIGIO Sequential Fert83010060M2026-02-05
00888937028454ORIGIO Sequential Fert83020010M2026-02-05
00888937028461ORIGIO Sequential Fert83020060M2026-02-05
00888937028607SynVitro Flush15840125M2026-02-05
00888937028959Origio Handling83100060M83102026-02-05
00888937028966Origio Handling83100125M83102026-02-05
00888937028973Origio Handling83110060M83112026-02-05
00888937028980Origio Handling83110125M83112026-02-05
00888937029116SAGE 1-Step67010010M2026-02-05
00888937029123SAGE 1-Step67010060M2026-02-05
60888937029330ORIGIO Sperm Wash84050060M2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
20888937015069RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
20888937015076RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
20888937015083RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
20888937015090RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
20888937015106RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
20888937015113RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
20888937015120RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
20888937015137RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
20888937015144Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
20888937015151Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
20888937015168Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
20888937015175Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
20888937015182Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
20888937015199Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
20888937015212Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015768THE RUMI SystemCoopersurgical, Inc.HEW2022-11-10
00888937014778KOH Cup Sterilization Tray (KCT)Coopersurgical, Inc.HEW2022-10-31