AccessGUDID - DEVICE: Ambler Value Line (00190660196684)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Value Line
Version or Model: Lewis lens loop
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EC3725
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660196684
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Lewis lens loop, 5 3/8'', small 5.0mm x 6.0mm smooth loop, flat handle, 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?
13487	Enucleation scissors, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut tissue during surgery involving enucleation of the eye and/or its related structures (i.e., the removal of the eyeball to, e.g., remove a malignant tumour or to relieve intolerable pain in a blind eye). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNE	Snare, enucleating

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: e6e040cc-098e-4df8-8b89-50c5ba70e0e2
Public Version Date: February 03, 2023
Public Version Number: 2
DI Record Publish Date: January 04, 2021