AccessGUDID - DEVICE: SIGMOIDOSCOPIC (10653405000102)

GUDID

Device Identifier (DI) Information

Brand Name: SIGMOIDOSCOPIC
Version or Model: 0033050
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0033050
Company Name: Conmed Corporation

Primary DI Number: 10653405000102
Issuing Agency: GS1
Commercial Distribution End Date: June 25, 2018
Device Count: 20
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: SIGMOIDOSCOPIC Suction Instrument 18 Fr W/Winged Cap Control and 6 Foot (1.8m) Tubing

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?
35917	Surgical/emergency suction cannula, non-illuminating, single-use	An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCX	APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 7/32 Inch Outer Diameter
Length: 30 Centimeter
Device Size Text, specify: 18 French Outer Diameter
Length: 12 Inch
Outer Diameter: 6 Millimeter

Device Record Status

Public Device Record Key: 50ec9937-a0db-4177-91c9-1218e37695a1
Public Version Date: April 20, 2020
Public Version Number: 5
DI Record Publish Date: September 24, 2016