Device
DASTOOR PUPIL AND IRIS REPOSITOR, DOUBLE ENDED 1MM WIDE, NOTCHED TIP AND SPATULA SHAPED TIP, OL 13CM (5")
Manufacturer
ELMED INCORPORATED
ELMED INCORPORATED
Model: 35-62914
Catalog: 35-62914
DI: 00198506090912
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
DASTOOR PUPIL AND IRIS REPOSITOR, DOUBLE ENDED 1MM WIDE, NOTCHED TIP AND SPATULA SHAPED TIP, OL 13CM (5")
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
14592433-01e4-4420-8bca-855a3c239efc
Distribution Status:
In Commercial Distribution
DUNS Number:
049290364
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00198506090912
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45149
Name: Ophthalmic surgical procedure kit, non-medicated, reusable
Definition:
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. This is a reusable device.
FDA Product Codes
HNC
Specula, Ophthalmic