AccessGUDID - DEVICE: MSI Precision Specialty Instruments (00194613063337)

GUDID

Device Identifier (DI) Information

Brand Name: MSI Precision Specialty Instruments
Version or Model: 5-2175
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Med Saver, Inc.

Primary DI Number: 00194613063337
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 556623486 *Terms of Use

Device Description: Jaeger Lid Plate, Clear Lucite, 20mm X 35mm And 24mm X 35mm Curved Ends, And Overall Length Of 3 3/4" (93mm) Non Auto Clavable

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?
64302	Periocular/lacrimal retractor, hand-held, single-use	A hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNI	Retractor, 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 64f13de3-27a1-4236-87dc-c4686941e6e0
Public Version Date: August 23, 2024
Public Version Number: 1
DI Record Publish Date: August 15, 2024