FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331171567
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
9396-03
Catalog number
9396-03
Device description
"flash autoclave tray, 10"" x 6 1/2"" x 2 1/2"" (25.4 cm x 16.5 cm x 6.3 cm), w/ out lid"
Published
2022-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331171567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331171567008423311715678423311715670842331171567

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1877-860-6686info@novosurgical.com

Regulatory Flags#

DUNS number
033029433
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G586N6863510Novo SurgicalN6863-51N6863-512023-12-18
G586N6863530Novo SurgicalN6863-53N6863-532023-12-18
G586N6863540Novo SurgicalN6863-54N6863-542023-12-18
G586N6863550Novo SurgicalN6863-55N6863-552023-12-18
G586N6863580Novo SurgicalN6863-58N6863-582023-12-18
G586N6863590Novo SurgicalN6863-59N6863-592023-12-18
G586N98831250Novo SurgicalN98831-25N98831-252023-12-18
00842331174377Novo Surgical Inc. N3807-12N3807-122022-11-14
00842331153556Novo Surgical Inc. N6863-52N6863-522022-11-12
00842331165771Novo Surgical Inc. N6863-56N6863-562022-11-13
00842331169717Novo Surgical Inc. N6863-57N6863-572022-11-13
00842331170836Novo Surgical Inc. N3807-13N3807-132022-11-13
00842331194023Novo Surgical Inc. OP7195-242023-12-07
G586NS41500200Novo SurgicalNS4150020NS41500202025-09-15
G586NS41500250NovosurgicalNS4150025NS41500252025-09-15
G586NS720151200Novo SurgicalNS720-1512-02025-09-15
G586NS720155800Novo Surgical IncNS720-1558-0NS720-1558-02025-09-15
00842331192968Novo Surgical IncG1911-38IG-NS2023-08-21
G586NS80292210Novo SurgicalNS80-2922-1NS80-2922-12025-05-19
G586N8810500Novo SurgicalN8810-502025-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956460690CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
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10198956470613CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956482159CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956488533CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956491236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956492592CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956492998CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956494824CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
04046826447953Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495923Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495978Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
50198956435382CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-24
50198956248968CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956284027CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956293043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956304954CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956305630CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956308433CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956313703CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956322590CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956325607CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956331677CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956332292CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956348255CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956356526CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23