AccessGUDID - DEVICE: Kocher director (04250676712998)

GUDID

Device Identifier (DI) Information

Brand Name: Kocher director
Version or Model: 80-470-16
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80-470-16
Company Name: Spiggle & Theis Medizintechnik GmbH

Primary DI Number: 04250676712998
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332893028 *Terms of Use

Device Description: with opening 12.5 mm, 16.5 cm

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:	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?
33433	ENT probe, reusable	A slender, rod-like, hand-held manual surgical instrument, typically with a blunt bulbous or pointed tip, used for exploring fistulas, cavities or wounds used during ear/nose/throat (ENT) intervention. The distal end of the instrument, before the bulb/point, may be bent at a right angle to the shaft. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	INSTRUMENT, ENT MANUAL SURGICAL

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac41caef-5eb5-4c34-bb74-7fe78d0b4436
Public Version Date: October 07, 2022
Public Version Number: 1
DI Record Publish Date: September 29, 2022