AccessGUDID - DEVICE: GEN2 (00840343700553)

GUDID

Device Identifier (DI) Information

Brand Name: GEN2
Version or Model: G2E900958
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G2E900958
Company Name: SURGIX MEDICAL LLC

Primary DI Number: 00840343700553
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080402644 *Terms of Use
Previous DI: G277G2E9009580

Device Description: HOUSE SEPARATOR BAYONET 1.5MM

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?
35915	Ear excavator	A hand-held manual surgical instrument designed for cutting, scraping, scooping and removing tissue during a surgical procedure in or around the ear, allowing the performance of specialized procedures such as removal of the cochlear cupola and microsurgery of the middle ear and the sinus timpani. It is made of high-grade stainless steel and typically designed as a double-ended instrument having a central handle with small and sharp spoon-, scoop-, or spatula-shaped blades that have cutting/gouging edges. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEN	Forceps, General & Plastic Surgery

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
Device Size Text, specify: Tip/Jaw Width 1.5 mm
Length: 6.75 Inch

Device Record Status

Public Device Record Key: faed2bd5-5e01-491a-9f3e-078eb353cee9
Public Version Date: October 26, 2022
Public Version Number: 1
DI Record Publish Date: October 18, 2022