AccessGUDID - DEVICE: MSI Precision Specialty Instruments (00194613011734)

GUDID

Device Identifier (DI) Information

Brand Name: MSI Precision Specialty Instruments
Version or Model: 5-6763
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Med Saver, Inc.

Primary DI Number: 00194613011734
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 556623486 *Terms of Use

Device Description: Carter Sphere Introducer and Holder Overall length 4 7/8" (125mm) Country Of Origin Germany

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?
32766	Orbital sphere implant introducer	A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNP	Introducer, sphere

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: 6bfab2d3-59a6-4513-89bc-6728ec26c8cd
Public Version Date: March 31, 2025
Public Version Number: 1
DI Record Publish Date: March 21, 2025