AccessGUDID - DEVICE: Arch Koh-Efficient (00888937015195)

GUDID

Device Identifier (DI) Information

Brand Name: Arch Koh-Efficient
Version or Model: KCS-ARCH-30
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Coopersurgical, Inc.

Primary DI Number: 00888937015195
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801895244 *Terms of Use

Device Description: Arch Koh-Efficient - 3.0 cm for use with the Advincula Arch Handle - Harmonic scalpel and laser

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47936	Colpotomy tube	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HEW	Culdoscope (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Inner Diameter 3.0 cm

Device Record Status

Public Device Record Key: 7e146be9-47e9-4f7d-905e-4bb7c8dcf2f7
Public Version Date: February 28, 2024
Public Version Number: 3
DI Record Publish Date: November 10, 2022