AccessGUDID - DEVICE: CONMED (10845854026151)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 9802A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9802A
Company Name: Conmed Corporation

Primary DI Number: 10845854026151
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use
Previous DI: 20845854026158

Device Description: ACROMIOPLASTY ELECTRODE MINI KIT

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:	Yes
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?
44093	Arthroscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAW	Neurological stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K823424	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd8f9bd4-22d1-4730-890a-3395d62dd3fe
Public Version Date: August 01, 2024
Public Version Number: 2
DI Record Publish Date: December 05, 2023