AccessGUDID - DEVICE: Ambler Surgical (00190660089665)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Capsular tension ring injector
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7285T
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660089665
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Capsular tension ring injector, 6 1/2'', curved shaft, hook pointed down, plunger mechanism, titanium, for use with Ophtec/AMO CTR's

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?
60448	Capsular tension ring inserter	A non-sterile hand-operated surgical instrument intended for the implantation of a capsular tension ring (CTR) into the crystalline lens capsular bag during intraocular lens (IOL) surgery (e.g., cataract extraction). It typically consists of a tubular distal tip with internal hooking wire connected to a proximal plunger mechanism, whereby the CTR is hooked and retracted into the tip, the tip inserted into the eye, and the CTR deployed using the plunger. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: f1af4729-88ec-4b7c-8ccb-e55fce7f3a07
Public Version Date: January 12, 2021
Public Version Number: 1
DI Record Publish Date: January 04, 2021