Aspirating Speculum

GUDID 00883475701340

CHARMANT INC.

Eyelid speculum, reusable
Primary Device ID00883475701340
NIH Device Record Keya6e55552-c572-4254-8dcb-1ef0e4cc7843
Commercial Distribution StatusIn Commercial Distribution
Brand NameAspirating Speculum
Version Model Number37-0015
Company DUNS693742728
Company NameCHARMANT INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100883475701340 [Primary]

FDA Product Code

HNCSpecula, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


[00883475701340]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-26
Device Publish Date2023-09-18

Devices Manufactured by CHARMANT INC.

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00883475953305 - MS Round-Crescent-Flat2024-08-09
00883475953312 - MS Round-ST-Flat2024-08-09
00883475953329 - MS Round-ST-Flat2024-08-09
00883475953411 - MS Round-ST-CV2024-08-09
00883475953428 - MS Round-ST-CV2024-08-09
00883475651300 - IOL Hook2023-09-26
00883475651324 - Capsulorrhexis Forceps2023-09-26

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