AccessGUDID - DEVICE: Ambler Value Line (00190660196981)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Value Line
Version or Model: Bowman lacrimal probe
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EC9894
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660196981
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Bowman lacrimal probe, 5 7/8'', double-ended, size #3 and #4 blunt ends, malleable sterling silver, economy pattern recommended for clinics/mission trips only

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
HNL	Probe, 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: fb2baa0a-9f6e-432b-813d-48e9cca8f2a0
Public Version Date: January 12, 2021
Public Version Number: 1
DI Record Publish Date: January 04, 2021