AccessGUDID - DEVICE: Stephens Instruments (00810799039958)

GUDID

Device Identifier (DI) Information

Brand Name: Stephens Instruments
Version or Model: SSD8 1015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SSD8 1015
Company Name: KRISHNA IMPORTS INC

Primary DI Number: 00810799039958
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081853285 *Terms of Use

Device Description: Castroviejo Lacrimal Dilator, Double Ended, Med/Fine Tip, Single Use, 10/Box

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:	Yes
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?
34035	Lacrimal dilator, single-use	A sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a single-use 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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 416e45dd-c71d-47e2-affd-91e56ce60e9a
Public Version Date: October 01, 2020
Public Version Number: 1
DI Record Publish Date: September 23, 2020