Needle Holder(Thin tips)

GUDID 00883475679052

CHARMANT INC.

Suturing needle holder, reusable
Primary Device ID00883475679052
NIH Device Record Key5b3f1b67-27c6-4914-8b4e-764b02ecaa5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeedle Holder(Thin tips)
Version Model Number37-0013
Company DUNS693742728
Company NameCHARMANT INC.
Device Count1
DM Exemptfalse
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
GS100883475679052 [Primary]

FDA Product Code

HNMNeedle, Ophthalmic Suturing

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

Moist Heat or Steam Sterilization


[00883475679052]

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

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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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