AccessGUDID - DEVICE: Ambler Surgical (00190660089153)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Interchangeable-Tip I/A system curved tip
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90-322E
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660089153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Interchangeable-Tip I/A system curved tip, 16 gauge outer sleeve, 21 gauge inner sleeve, 0.5mm aspiration port for rapid removal of visco material, stainless steel

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?
63231	Ophthalmic surgical irrigation/infusion/aspiration handle, reusable	A hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYG	Device, irrigation, ocular surgery

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: a7b44930-d82e-441e-9430-6f07bb18a7f1
Public Version Date: January 12, 2021
Public Version Number: 1
DI Record Publish Date: January 04, 2021