AccessGUDID - DEVICE: TIANNUO / TNMED (06945033901211)

GUDID

Device Identifier (DI) Information

Brand Name: TIANNUO / TNMED
Version or Model: RS-4R28W
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lianyungang Tiannuo Optical Instrument Co., Ltd.

Primary DI Number: 06945033901211
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 420658999 *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":	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?
12318	Lens expressor	A manual ophthalmic surgical instrument designed for pressing or squeezing the natural lens from the eye. It is typically a hand-held device with the working end configured as a hook, ring, or other appropriate shape. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HMH	Rack, Skiascopic

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: 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: 5d0c588c-bf7e-41c3-9479-d40b55ca0933
Public Version Date: October 25, 2018
Public Version Number: 1
DI Record Publish Date: September 24, 2018