FDA.report

Novo Surgical Inc.

Primary DI
00842331147692
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
OB6361-12
Catalog number
OB6361-12
Device description
doyen tumor screw, 24.0 mm diameter, 6 1/2" (16.5 cm)
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

Related Records

Contact Domains

Product Codes

CodeName
KOHInstrument, Manual, General Obstetric-Gynecologic

Product Code Classifications

CodeDeviceSpecialtyClass
KOHInstrument, Manual, General Obstetric-GynecologicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842331147692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331147692008423311476928423311476920842331147692

GMDN Terms

TermDefinition
Crown surgical drill bit, reusableA shaft of metal with a hollow centre designed for overdrilling a surgical screw or screw shaft to expose it for its removal, with another instrument, when the screw head has become defective or detached. The device is commonly called a "hollow mill" or "crown drill", but may also be referred to as a "hollow reamer", and is designed as a cylindrical hollow shell with a thin wall that has saw teeth at the cutting edge. It is inserted into a surgical power tool for rotation. This device may also be used to obtain core bone biopsies. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
M8030030134Baby Tischler Biopsy Punch TitaniumMEDGYN PRODUCTS, INC.KOH2025-11-16
M8030030139Tischler Biopsy Punch TitaniumMEDGYN PRODUCTS, INC.KOH2025-11-16
M803029801Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803029802Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803029803Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803029804Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803029811Baby Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803029812Baby Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803029813Baby Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803029814Baby Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030101Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M80303010110Tischler Biopsy Punch 10" (254mm)MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030102Baby Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M80303010210Baby Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030103Kevorkian Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M80303010310Kevorkian Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030104Rotating Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030105Rotating Baby Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030106Rotating Kevorkian Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030107Rotating Burke Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030108Rotating Biopsy Punch Handle OnlyMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030109Burke Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030110Eppendorfer Biopsy ForcepsMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030113Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030114Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030115Tischler-Kevorkian Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030116Tischler-Kevorkian Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030117Wittner Biopsy Punch 8.5" (216mm)MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030118Tischler Biopsy Punch Titanium MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030119Baby Tischler Biopsy Punch TitaniumMEDGYN PRODUCTS, INC.KOH2025-11-16