nexis/arcad® ACC1001P0016

GUDID 03700879509082

Module

NOVASTEP

Device sterilization/disinfection container, reusable
Primary Device ID03700879509082
NIH Device Record Keyf0d241f2-8fa6-4196-ab34-a98273e52f12
Commercial Distribution StatusIn Commercial Distribution
Brand Namenexis/arcad®
Version Model NumberACC1001P0016
Catalog NumberACC1001P0016
Company DUNS264255288
Company NameNOVASTEP
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com
Phone+33299338650
Emailcontact@novastep-ortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103700879509082 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


[03700879509082]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-28
Device Publish Date2023-12-20

Devices Manufactured by NOVASTEP

03700879515342 - PECA® 2.02025-06-25 Bunion implant Ø3 lg16
03700879515359 - PECA® 2.02025-06-25 Bunion implant Ø3 lg18
03700879515366 - PECA® 2.02025-06-25 Bunion implant Ø3 lg20
03700879515373 - PECA® 2.02025-06-25 Bunion implant Ø3 lg22
03700879515380 - PECA® 2.02025-06-25 Bunion implant Ø3 lg24
03700879515397 - PECA® 2.02025-06-25 Bunion implant Ø3 lg26
03700879516196 - PECA® 2.02025-06-25 Removal AO T15 screwdriver tip
03700879516202 - PECA® 2.02025-06-25 Exact2-T®15 AO screwdriver tip

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.