FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331154294
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7215-30
Catalog number
E7215-30
Device description
mcgee oval window rasp, shaft angled 20 degrees, 6 1/2" (16.5 cm), small, 0.4 mm diameter rasp
Published
2022-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYYRasp, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYYRasp, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331154294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331154294008423311542948423311542940842331154294

GMDN Terms#

Term, Definition table
TermDefinition
FacebowA caliper-like dynamic dental instrument intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G586N8810500Novo SurgicalN8810-502025-05-19
G586NS38796080NOVOSURGICALNS38-796-08NS38-796-082025-05-02
G586NS50468110Novo SurgicalNS50-4681-1NS50-4681-12025-05-02
G586G171631E0NovosurgicalG1716-31E2025-04-17
G586G311041NC0Novo SurgicalG3110-41NC2025-03-21
G586N697205A0NovosurgicalN6972-05AN6972-05A2025-02-06
G586N697206A0NovosurgicalN6972-06AN6972-05A2025-02-06
G586NS02533010Novo SurgicalNS02-5330-1NS02-5330-12025-02-06
G586NS5230002SPFB10Novo SurgicalNS52-300-02SPFB-1NS02-5330-12025-02-06
G5862562529S0Novosurgical25625-29S2025-01-02
G586N6969090NovosurgicalN6969-092025-01-02
G586N6971710NovosurgicalN6971-712025-01-02
G586N6971730NovosurgicalN6971-732025-01-02
G586N6972700NovosurgicalN6972-702025-01-02
G586NS47110610NovosurgicalNS47-1106-12025-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811112798INKAThe Trustee for KAISER FAMILY TRUSTJYY2025-12-02
09348811112804INKAThe Trustee for KAISER FAMILY TRUSTJYY2025-11-24
00757770420384Bausch + LombBausch & Lomb IncorporatedJYY2025-08-05
00757770404384Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00757770422722Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00757770435647Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00887482035160Symmetry Surgical®SYMMETRY SURGICAL INC.JYY2024-08-12
00887482120057Symmetry Surgical®SYMMETRY SURGICAL INC.JYY2024-08-12
00840183525958BR Surgical, LLCBR Surgical, LLCJYY2024-06-03
G586E7773430Novo SurgicalNOVO SURGICAL, INC.JYY2023-12-18
G586E7773450Novo SurgicalNOVO SURGICAL, INC.JYY2023-12-18
00190776324308MillenniumAvalign Technologies, Inc.JYY2023-11-13
00190776324346MillenniumAvalign Technologies, Inc.JYY2023-11-13
00190776324292MILLENNIUMAvalign Technologies, Inc.JYY2023-09-28
00190776324339MILLENNIUMAvalign Technologies, Inc.JYY2023-09-28
00190776376529AvalignAvalign Technologies, Inc.JYY2023-09-28
00810123201525Adler Instrument CompanyAdler, Inc.JYY2023-03-15
00840319742624Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742631Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742648Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742655Hayden MedicalHayden Medical, Inc.JYY2023-03-14
54026704807715PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807777PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807739PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807753PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807746PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807722PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807760PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
00842331174773Novo Surgical Inc. NOVO SURGICAL, INC.JYY2022-11-14
00842331174780Novo Surgical Inc. NOVO SURGICAL, INC.JYY2022-11-14