AccessGUDID - DEVICE: Gen2 (00840343707835)

GUDID

Device Identifier (DI) Information

Brand Name: Gen2
Version or Model: G2N62047
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G2N62047
Company Name: SURGIX MEDICAL LLC

Primary DI Number: 00840343707835
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080402644 *Terms of Use
Previous DI: G277G2N620470

Device Description: DOUBLE ACTION RONGEUR, 14.5", 8X18MM

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?
32853	Orthopaedic joint/limb rongeur	A hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAE	Rongeur, Manual

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
Length: 14.5 Inch
Device Size Text, specify: Tip Width: 8mm
Device Size Text, specify: Direction: Tip Length:18mm

Device Record Status

Public Device Record Key: 5f8bb840-b977-4491-96fe-cfe5b9d5ab0d
Public Version Date: October 28, 2022
Public Version Number: 1
DI Record Publish Date: October 20, 2022