AccessGUDID - DEVICE: UNFOLDER EMERALD (15050474534503)

GUDID

Device Identifier (DI) Information

Brand Name: UNFOLDER EMERALD
Version or Model: EMERALDXL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EMERALDXL
Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.

Primary DI Number: 15050474534503
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103021940 *Terms of Use

Device Description: MODEL EMERALDXL HANDPIECE, 690735

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?
47724	Manual intraocular lens injector, reusable	A hand-held manual ophthalmic surgical instrument designed to expel (launch) a prepared (folded) intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of lightweight metal materials [e.g., titanium (Ti)]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYB	LENS, GUIDE, INTRAOCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961242	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 2bf65e8a-fbf4-4e9a-885e-8cc8d9878746
Public Version Date: December 08, 2022
Public Version Number: 3
DI Record Publish Date: February 13, 2019