Ocular Exam Standard Speculum N6510

GUDID 00812594012525

Disposable Standard Speculum

NEOTECH PRODUCTS, INC.

Eyelid speculum, single-use
Primary Device ID00812594012525
NIH Device Record Keyef7dcbf9-7e85-4b65-b272-963566240f7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOcular Exam Standard Speculum
Version Model Number10812594012522
Catalog NumberN6510
Company DUNS198013435
Company NameNEOTECH PRODUCTS, INC.
Device Count20
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812594012525 [Unit of Use]
GS110812594012522 [Primary]

FDA Product Code

FXGSpecula Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


[00812594012525]

High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-22
Device Publish Date2021-06-14

Devices Manufactured by NEOTECH PRODUCTS, INC.

00812594011405 - Little Sucker Cover2022-05-31 Protective Cover (Qty. 50)
10812594010795 - Meconium Aspirator2022-01-24
10812594010818 - Meconium Aspirator Tinted2022-01-24
10812594012584 - NeoBond Shapes (Hearts) (N7426)2022-01-24
00812594010330 - NeoBond2021-06-23 Hydrocolloid Strip
00812594011603 - NeoBond2021-06-23 Hydrocolloid Roll - 1" x 15' Roll
00812594012198 - EZCare Softouch - Pink2021-06-23 Trach Holder 6" - Pink
00812594012204 - EZCare Softouch - Pink2021-06-23 Trach Holder 7" - Pink

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