AccessGUDID - DEVICE: Ambler Surgical (00190660106249)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Southern eye bank of New Orleans cutting block
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 33-0002
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660106249
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Southern eye bank of New Orleans cutting block, 41 x 28 x 19mm, teflon block with two wells

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?
58387	Surgical cutting/shaping board, reusable	A stiff, plastic device intended to be used as a surface to trim/contour objects or tissues (e.g., implants, transplants) in an operating room (OR) or other clean room during a surgical procedure. It may be flat or contoured and/or have measurement graduations as a visual approximation aid. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNJ	Punch, corneo-scleral

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: 6fb19a5f-9132-45ed-8156-a65ab91a7354
Public Version Date: November 09, 2022
Public Version Number: 3
DI Record Publish Date: January 04, 2021