AccessGUDID - DEVICE: DETACHAPORT (30653405036498)

GUDID

Device Identifier (DI) Information

Brand Name: DETACHAPORT
Version or Model: 1-7021
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1-7021
Company Name: Conmed Corporation

Primary DI Number: 30653405036498
Issuing Agency: GS1
Commercial Distribution End Date: November 17, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: DETACHAPORT OBTURATOR AND SEAL SET WITH REDUCERS, (1) 10MM X 100MM OBTURATOR, (2) 10/12MM SEAL SETS

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:	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?
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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Seal Set
Length: 100 Millimeter
Outer Diameter: 10 Millimeter

Device Record Status

Public Device Record Key: 43294400-ca73-476f-a486-c9dd63b0ad93
Public Version Date: November 18, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016