AccessGUDID - DEVICE: NA (20845854038373)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 60-3950-083
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-3950-083
Company Name: Conmed Corporation

Primary DI Number: 20845854038373
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: ARTHROSCOPY SPECIMEN COLLECTOR AND FILTER

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?
62059	Suction system filter, tissue, sterile	A sterile device intended to be fitted into a suction system bottle/canister to separate tissue from the aspirate during a surgical procedure; the tissue may be subsequently used for various diagnostic/therapeutic purposes (e.g., autologous fat tissue transfer, histological/pathological analysis). It is a meshed flat or tubular piece; accessory components (e.g., container sealing rings, tubing, filter housing) may be included. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BTA	PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

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: 77fd8632-c6f8-4eb3-b118-b3754157b2a1
Public Version Date: June 07, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2016