AccessGUDID - DEVICE: WELLS ENUCLEATION SPOON (00192896013612)

GUDID

Device Identifier (DI) Information

Brand Name: WELLS ENUCLEATION SPOON
Version or Model: 12-4750
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12-4750
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896013612
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: WELLS ENUCLEATION SPOON ANGLED HEAD

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?
35153	Lens spoon	A hand-held ophthalmic surgical instrument used in ophthalmic surgery to manipulate/remove the lens of the eye. It is typically made of high-grade stainless steel and has a spoon-shaped distal working end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNB	Spoon, 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
Dry Heat 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: ad13604e-43e5-49c6-918b-2224eca121fa
Public Version Date: October 19, 2018
Public Version Number: 1
DI Record Publish Date: September 18, 2018