AccessGUDID - DEVICE: Ambler Surgical (00190660192259)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Camellin style LASEK trephine
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2107E
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660192259
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Camellin style LASEK trephine, 4 1/2'', double-ended, 8.0mm and 9.0mm trephines, flat 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?
62785	Ophthalmic surgery fluid retention ring	A sterile ophthalmic device intended to be placed on the cornea to provide a physical barrier for fluid retention of the eye during ophthalmic surgery. It is a bevelled, hollow cylinder made of high-grade stainless steel, similar in shape to a non-cutting corneal trephine, with a double-walled vacuum ring intended to create an airtight seal. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRH	Trephine, manual, ophthalmic

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: c75dd675-7115-49fd-8f98-301238e1dcfd
Public Version Date: January 12, 2021
Public Version Number: 1
DI Record Publish Date: January 04, 2021