FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E8310320
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E8310-32
Catalog number
E8310-32
Device description
"logan bow, w/ out teeth, 1 1/4"" wide"
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
KCRFACEBOW

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCRFacebowDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586E8310320PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Lip traction bowAn arch-shaped device intended to provide self-retaining traction of the cheeks (pull cheeks towards the midline) during surgical cleft lip repair, to stabilize and reduce the tension on the repair suture line; some forms may be designed to additionally provide protection after surgery. It may have spikes or use tape for skin attachment, is made of metal, and is available in various shapes and sizes. This is a reusable device intended to be sterilized prior to use.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D040022720#2240Q ART/#8645 FACE BOW IN BOXWHIP-MIX CORPORATIONKCR2025-09-11
07615208459579UTS 3D/ UTS CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKCR2024-06-26
07615208460483UTS 3D/ UTS CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKCR2024-06-26
06973329326059Reverse Pull Headgear(Face Mask), Middle, RedAstar Orthodontics Inc.KCR2023-12-31
06973329326066Reverse Pull Headgear(Face Mask), Middle, BlueAstar Orthodontics Inc.KCR2023-12-31
06973329326073Reverse Pull Headgear(Face Mask), Middle, YellowAstar Orthodontics Inc.KCR2023-12-31
06973329326080Reverse Pull Headgear(Face Mask), Middle, OrangeAstar Orthodontics Inc.KCR2023-12-31
06973329326097Reverse Pull Headgear(Face Mask), Middle, PurpleAstar Orthodontics Inc.KCR2023-12-31
06973329326103Reverse Pull Headgear(Face Mask), Middle, GreenAstar Orthodontics Inc.KCR2023-12-31
G586E8310210Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310220Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310310Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310330Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
E1996625211CRS Set 15Candulor AGKCR2023-11-16
E1996624511Bite forkCandulor AGKCR2023-11-16
E1996624531Bite fork SetCandulor AGKCR2023-11-16
E1996625131CRS Set 10Candulor AGKCR2023-11-16
D04020002950Unit-Assy SlidematicWHIP-MIX CORPORATIONKCR2023-10-27
D04020011540Unit Assembly 9645 FBWHIP-MIX CORPORATIONKCR2023-10-27
00850211006144Facial Plane RelatorHO DENTAL COMPANY LLCKCR2023-05-17
00842331179730Novo Surgical Inc. NOVO SURGICAL, INC.KCR2022-11-14
E4942186801accessoryAmann Girrbach AGKCR2022-09-08
E4942186901accessoryAmann Girrbach AGKCR2022-09-08
E4942176951accessoryAmann Girrbach AGKCR2022-09-07
E4942186071accessoryAmann Girrbach AGKCR2022-09-07
E4942186351accessoryAmann Girrbach AGKCR2022-09-07
E4942176112accessoryAmann Girrbach AGKCR2022-08-22
E4942176611accessoryAmann Girrbach AGKCR2022-08-22
E4942179285accessoryAmann Girrbach AGKCR2022-08-22
E4942186001ArtexAmann Girrbach AGKCR2022-08-22