AccessGUDID - DEVICE: ELMED (00842180199606)

GUDID

Device Identifier (DI) Information

Brand Name: ELMED
Version or Model: 36-9153M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 36-9153M
Company Name: ELMED INCORPORATED

Primary DI Number: 00842180199606
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049290364 *Terms of Use

Device Description: "Multi-hole suction tubes, Five holes at tip. 5Fr. Working length 6-1/2in (16.5cm), M= PARTIALLY CLOSED TIP"

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:	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?
44067	ENT surgical procedure kit, non-medicated, reusable	A collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a reusable device.	Active	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: No 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: 76e207f9-bf57-427c-bd72-ac240b93e144
Public Version Date: May 21, 2024
Public Version Number: 1
DI Record Publish Date: May 13, 2024