AccessGUDID - DEVICE: Inami Ophthalmic Instruments (04547451332381)

GUDID

Device Identifier (DI) Information

Brand Name: Inami Ophthalmic Instruments
Version or Model: M-2215R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INAMI & CO., LTD.

Primary DI Number: 04547451332381
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690688742 *Terms of Use

Device Description: M-2215R TMH ORIGINAL edition, Right

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?
32751	Trabeculotome, reusable	A hand-held manual ophthalmic surgical instrument intended to be used to perform a trabeculotomy [surgical opening of the sinus venosus sclerae (Schlemm’s canal)] to reduce intraocular pressure (IOP) for the prevention/treatment of glaucoma. It is typically made of high-grade stainless steel, having a two-pronged fork at the distal end and a handle at the proximal end. It enables guided unroofing of Schlemm's canal (an endothelium-lined tube) through insertion of one of the prongs via incisions and flaps made in the eye. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNK	Probe, Trabeculotomy

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

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: cf4e7421-2472-49f0-b3ee-2e7e61938157
Public Version Date: April 10, 2024
Public Version Number: 2
DI Record Publish Date: October 26, 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
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: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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