AccessGUDID - DEVICE: TRUSITE® (00650551045694)

GUDID

Device Identifier (DI) Information

Brand Name: TRUSITE®
Version or Model: 3630
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3630
Company Name: PMT CORPORATION

Primary DI Number: 00650551045694
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039576871 *Terms of Use

Device Description: MAGNETIC INTERNAL PORT LOCATOR

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":	Yes
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?
46583	Tissue expander injection port locator	A small, hand-held, manually-operated, sterile device designed to assist with the location of the subcutaneous injection port of an implanted tissue expander prior to the insertion of a filling needle into the port in order to fill the tissue expander with, e.g., saline. It is moved over the surface of the skin at the point where the concealed injection site is situated and an indicator, e.g., a small magnet, reacts to the metal material of the port, indicating where it is located. Repetition of this locating process on several axes provides the exact location of the injection site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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: 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: 414622b1-119d-40a1-848b-ec57e307ca49
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-626-5463
Email: info@pmtcorp.com

Phone: 800-626-5463
Email: intl@pmtcorp.com

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