AccessGUDID - DEVICE: Lacrimal dilator, reusable (03760087126075)

GUDID

Device Identifier (DI) Information

Brand Name: Lacrimal dilator, reusable
Version or Model: DOUBLE DILATOR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A8.4050
Company Name: FCI S A S FCI 20 22

Primary DI Number: 03760087126075
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 763408366 *Terms of Use

Device Description: 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.

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):	Yes
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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 119 Millimeter

Device Record Status

Public Device Record Key: 72c9b2de-583a-4a9b-8fc5-674a0c084fa2
Public Version Date: March 05, 2020
Public Version Number: 1
DI Record Publish Date: February 26, 2020