AccessGUDID - DEVICE: Landers Short Two Strut Vitrectomy Lens Ring (00630238077255)

GUDID

Device Identifier (DI) Information

Brand Name: Landers Short Two Strut Vitrectomy Lens Ring
Version or Model: OLVR-S2S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OCULAR INSTRUMENTS, INC.

Primary DI Number: 00630238077255
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 046212387 *Terms of Use

Device Description: No description.

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):	No
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?
32758	Flieringa ophthalmic ring	A circular band, typically stainless steel, sutured to the sclera to prevent collapse of the globe (sphere) during difficult intraocular operations. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNH	Ring, Ophthalmic (Flieringa)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K912269	000

Device Exempt from Premarket Submission: No 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: 6a777a1b-7651-4899-b5c4-8b11e8dfed56
Public Version Date: June 20, 2019
Public Version Number: 1
DI Record Publish Date: June 12, 2019