AccessGUDID - DEVICE: TIANNUO / TNMED (06945033900764)

GUDID

Device Identifier (DI) Information

Brand Name: TIANNUO / TNMED
Version or Model: W-AL232
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lianyungang Tiannuo Optical Instrument Co., Ltd.

Primary DI Number: 06945033900764
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?
36068	Trial lens set	A set of ophthalmic trial lenses of various dioptric powers intended for vision testing to determine the required refraction. This device typically includes other related devices such as a trial frame into which the trial lenses can be rapidly exchanged during the examination.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HPC	Set, Lens, Trial, Ophthalmic

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: 338689f8-c744-4dc8-9d15-35b982284f2d
Public Version Date: October 25, 2018
Public Version Number: 1
DI Record Publish Date: September 24, 2018