FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E93535810
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E93535-81
Catalog number
E93535-81
Device description
"zenith agris-dingman submammary dissector, set of 2, right & left, extra-long, 16"" (40.6 cm)"
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586E93535810PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400620MillenniumAvalign Technologies, Inc.GAD2026-07-19
00190776400330MillenniumAvalign Technologies, Inc.GAD2026-07-17
00190776400361MillenniumAvalign Technologies, Inc.GAD2026-07-17
00190776400453MillenniumAvalign Technologies, Inc.GAD2026-07-17
00198506039072ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
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00198506092190ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092206ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092213ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092220ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092237ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
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00198506092251ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092268ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
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00198506092299ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
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00198506092312ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092329ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
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00198506092626ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00810220800454Adler Instrument CompanyAdler, Inc.GAD2026-07-17
04058749048186NAFehling Instruments GmbH & Co. KGGAD2026-07-17
04058749049800NAFehling Instruments GmbH & Co. KGGAD2026-07-17
04058749078008NAFehling Instruments GmbH & Co. KGGAD2026-07-17
B382SD907808200Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD907808210Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD9079001010Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD97247105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-17