AccessGUDID - DEVICE: Acessa ProVu System (15420045515284)

GUDID

Device Identifier (DI) Information

Brand Name: Acessa ProVu System
Version or Model: 5200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5200
Company Name: Hologic, Inc.

Primary DI Number: 15420045515284
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: The Acessa ProVu Table Top Field Generator

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?
67289	Electromagnetic surgical navigation device tracking system field generator	An electrically powered device intended to generate an electromagnetic (EM) field for tracking of surgical instruments with respect to real-time ultrasound images during surgery. It is designed to be connected to a control unit which is in turn connected to an endoscopic handpiece and ultrasound transducer which both feature magnetic guidance sensors. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFG	COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -34 and 65 Degrees Celsius
Handling Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65f27caa-3541-4cba-844b-f31272384025
Public Version Date: September 16, 2024
Public Version Number: 3
DI Record Publish Date: November 08, 2022

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +1(800)442-9892
Email: CustomerSupport@hologic.com

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