AccessGUDID - DEVICE: Ace Medical co (00840217907293)

GUDID

Device Identifier (DI) Information

Brand Name: Ace Medical co
Version or Model: 52-097-30/28B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 52-097-30/28B
Company Name: Ebner Medical, LLC

Primary DI Number: 00840217907293
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106135367 *Terms of Use

Device Description: Black Caspar-style IVD Rongeur w/teeth, 3mm up, 11"

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?
33442	Craniofacial rongeur, reusable	A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTX	Rongeur

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
Length: 11 Inch
Width: 3 Millimeter

Device Record Status

Public Device Record Key: 993ebe4b-c3ab-4b5e-bb83-c750c70c5895
Public Version Date: January 29, 2024
Public Version Number: 2
DI Record Publish Date: November 08, 2022