AccessGUDID - DEVICE: Phaco Tip MST .9mm 30 Deg Straight (00844685000548)

GUDID

Device Identifier (DI) Information

Brand Name: Phaco Tip MST .9mm 30 Deg Straight
Version or Model: PT-27930-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PT-27930-1
Company Name: MICROSURGICAL TECHNOLOGY, INC.

Primary DI Number: 00844685000548
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 097824130 *Terms of Use

Device Description: No description.

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":	Yes
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?
34901	Phacoemulsification system handpiece tip, reusable	A device that is attached to a dedicated handpiece for insertion into the eye to deliver energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). It may facilitate, via the handpiece, the irrigation/suction needed for the removal of debris. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQC	Unit, Phacofragmentation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K943672	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Radiation 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: 99a29e26-483f-45ae-8c45-5401e5812a35
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016