FDA.report

Novo Surgical Inc.

Primary DI
00842331156663
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
NSOS1544-1
Catalog number
NSOS1544-1
Device description
t-handle corkscrew, black handle,(19.0 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
HWICorkscrew

Product Code Classifications

CodeDeviceSpecialtyClass
HWICorkscrewOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842331156663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331156663008423311566638423311566630842331156663

GMDN Terms

TermDefinition
Myoma screw, reusableA hand-held manual surgical instrument designed to engage, stabilize, and manipulate a myoma (i.e., a uterine fibroid) and other gynaecological tissues during their surgical removal. It is typically a one-piece instrument designed as a corkscrew having a pointed helicoidal stainless steel screw at the distal end, with a long slender shaft and a handle at the proximal end; it may be inserted through another device (e.g., laparoscope, hysteroscope, trocar) or be used during open surgery. 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
00190776416683MillenniumAvalign Technologies, Inc.HWI2026-02-16
00190776402471MillenniumAvalign Technologies, Inc.HWI2025-06-23
00810123207916Adler Instrument CompanyAdler, Inc.HWI2024-10-18
00841036284923N/ABIOMET MICROFIXATION, INCHWI2024-09-25
00822409100798N/AOrtho Development CorporationHWI2023-10-06
00190776264499AvalignAvalign Technologies, Inc.HWI2023-09-28
00190776292799MILLENNIUMAvalign Technologies, Inc.HWI2023-09-28
07898506815272QuinelatoSchobell Industrial LtdaHWI2023-07-06
54026704810999PILLINGTELEFLEX INCORPORATEDHWI2022-12-08
00643169092020n/aMEDTRONIC SOFAMOR DANEK, INC.HWI2022-11-21
00673978058436Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-14
00673978129471Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-08
00673978131016Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-08
00190776183028MillenniumAVALIGN TECHNOLOGIES, INC.HWI2021-11-01
00190776183035MillenniumAVALIGN TECHNOLOGIES, INC.HWI2021-11-01
00190776183042MillenniumAVALIGN TECHNOLOGIES, INC.HWI2021-11-01
00887868482854Cinch Modular AttachmentsBiomet Orthopedics, LLCHWI2021-03-24
00190660082734Ambler SurgicalAMBLER SURGICAL CORP.HWI2021-01-04
00889024595491Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595507Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595514Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595521Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595538Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595545Microfracture AwlZimmer, Inc.HWI2020-10-26
00841036284985N/ABIOMET MICROFIXATION, INCHWI2020-06-30
00847538010510DePuy SythesSYMMETRY MEDICAL INC.HWI2020-05-19
00847538010619DePuy SythesSYMMETRY MEDICAL INC.HWI2020-05-19
00880304608450CINCH MODULAR ATTACHMENTSBiomet Orthopedics, LLCHWI2020-05-15
04038653154586AESCULAPAesculap AGHWI2020-04-21
04038653154593AESCULAPAesculap AGHWI2020-04-21