AccessGUDID - DEVICE: Internal Micro Incision Gauges (08175700106627)

GUDID

Device Identifier (DI) Information

Brand Name: Internal Micro Incision Gauges
Version or Model: AS2-009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS2-009
Company Name: AURORA SURGICAL, LLC

Primary DI Number: 08175700106627
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968368832 *Terms of Use

Device Description: Internal Micro Incision Gauges

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):	No
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?
44796	Medical ruler, reusable	A small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent rigid or bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws, endodontic files/rasps). It is not an implant sizer/prosthesis trial of a predetermined size, nor is it dedicated to wound measurements. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOE	Caliper, Ophthalmic

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
No Device Sizes

Device Record Status

Public Device Record Key: b1c6069b-814b-4c29-9ecf-5beb5b0e2791
Public Version Date: September 11, 2024
Public Version Number: 2
DI Record Publish Date: November 14, 2022