AccessGUDID - DEVICE: ONE (03700483603428)

GUDID

Device Identifier (DI) Information

Brand Name: ONE
Version or Model: OU LC GUIDE RING FOR ARTIFICIAL CHAMBER
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 19186
Company Name: MORIA SA

Primary DI Number: 03700483603428
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 275937506 *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:	Yes
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?
45358	Corneal resection holder, single-use	A device designed to hold donated corneal tissue so that it can be resected in preparation for transplantation. The device may be in the form of a pedestal, with retention and locking rings, upon which the donated cornea is placed and inflated with air, or some other material, to simulate the pressure of the anterior chamber of the eye for the procedure. This method allows resection from the epithelial side of the cornea. The device may also include tubing and clips, and inflation is typically achieved manually with a syringe. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRH	Trephine, Manual, 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: ed0c3da7-6056-4d34-a0ef-63b10c3caf2f
Public Version Date: January 08, 2024
Public Version Number: 1
DI Record Publish Date: December 29, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
03700483603435	5	03700483603428		In Commercial Distribution

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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