AccessGUDID - DEVICE: Ambler Surgical (00190660030926)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Hosford lacrimal dilator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9887E
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660030926
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Hosford lacrimal dilator, 5 1/2'', double-ended, one 2.0mm blunted tapered end and one gradually tapered end, round knurled handle

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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 3fde413d-0832-4205-92f4-02cbfa4133d7
Public Version Date: January 12, 2021
Public Version Number: 1
DI Record Publish Date: January 04, 2021