AccessGUDID - DEVICE: MIRA (00850038042066)

GUDID

Device Identifier (DI) Information

Brand Name: MIRA
Version or Model: 180-050000-102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MIRA-SUD-MPS
Company Name: Virtual Incision Corporation

Primary DI Number: 00850038042066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041508596 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
65882	Robotic electrosurgical instrument, bipolar/monopolar	An electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in both a bipolar and monopolar configuration from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It includes a long thin body with a proximal housing intended to attach to the robotic arm, and includes the distal bipolar/monopolar electrodes in a variety of forms (e.g., forceps, hook, tip). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SAB	Table Mounted Miniaturized Electromechanical Surgical System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN230025	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: feba0ab0-7c31-4778-a5c2-9f9a6c138c1f
Public Version Date: July 02, 2024
Public Version Number: 1
DI Record Publish Date: June 24, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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