AccessGUDID - DEVICE: Stephens Instruments (00810799037190)

GUDID

Device Identifier (DI) Information

Brand Name: Stephens Instruments
Version or Model: S8-1020M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S8-1020M
Company Name: KRISHNA IMPORTS INC

Primary DI Number: 00810799037190
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081853285 *Terms of Use

Device Description: Muldon Lacrimal Dilator

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?
35010	Lacrimal dilator, reusable	A hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNW	Dilator, lachrymal

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5f9004d4-ecd1-4ea1-8c5a-ff30c10c580f
Public Version Date: September 30, 2020
Public Version Number: 1
DI Record Publish Date: September 22, 2020