AccessGUDID - DEVICE: Gen2 (00840343700263)

GUDID

Device Identifier (DI) Information

Brand Name: Gen2
Version or Model: G2E16660
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G2E16660
Company Name: SURGIX MEDICAL LLC

Primary DI Number: 00840343700263
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080402644 *Terms of Use
Previous DI: G277G2E166600

Device Description: HOUSE GELFOAM PRESS 12x15mm PL

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?
33393	Gelfoam punch	A manual instrument designed to punch circles of various sizes from a piece of Gelfoam (a sterile compressed gelatin sponge having haemostatic properties which usually absorbs completely within four to six weeks) typically used to help construct ossicular replacements during middle ear surgery. 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: 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: Width size 12 mm
Device Size Text, specify: Overall Length 5 inches
Length: 15 Millimeter

Device Record Status

Public Device Record Key: 6fc78e33-e9e8-44ed-8011-e0d767d4cb83
Public Version Date: October 26, 2022
Public Version Number: 1
DI Record Publish Date: October 18, 2022