AccessGUDID - DEVICE: Rumex (00840159905111)

GUDID

Device Identifier (DI) Information

Brand Name: Rumex
Version or Model: 12-5188
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12-5188
Company Name: RUMEX INTERNATIONAL CORP.

Primary DI Number: 00840159905111
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041546137 *Terms of Use

Device Description: Fixation Plate, 23/25 Ga

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?
62917	Eyeball fixation instrument, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used for fixation of the eyeball during a variety of ocular procedures. The distal end is configured as an open or closed ring with a fixed or swivelling attachment to a handle; the ring may be smooth or have blunt teeth. The instrument is typically metallic. 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 [?]
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 [?]
Dry Heat Sterilization
Ethylene Oxide
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: 9cbf081a-90ce-4a60-997f-dca8e42aff51
Public Version Date: June 30, 2020
Public Version Number: 1
DI Record Publish Date: June 22, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES