AccessGUDID - DEVICE: DETACHAPORT (30653405037099)

GUDID

Device Identifier (DI) Information

Brand Name: DETACHAPORT
Version or Model: 1-7057
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1-7057
Company Name: Conmed Corporation

Primary DI Number: 30653405037099
Issuing Agency: GS1
Commercial Distribution End Date: March 22, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: DETACHAPORT 12MM OPEN ENTRY WEDGE, MULTIPLE USE OPEN ENTRY TROCAR WEDGE

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":	No
For Single-Use:	No
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?
37148	Laparoscopic access cannula, reusable	A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K952977	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Open Entry Wedge

Device Record Status

Public Device Record Key: 2701a25e-93e6-4be8-85d8-3be590c9d4ed
Public Version Date: March 23, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016