FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331171772
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
OB6441-32
Catalog number
OB6441-32
Device description
braun-stadler episiotomy scissors, 8 1/4" (21.0 cm)
Published
2022-11-13
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
HDKScissors, Episiotomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDKScissors, EpisiotomyObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331171772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331171772008423311717728423311717720842331171772

GMDN Terms#

Term, Definition table
TermDefinition
Gynaecological scissors, reusableA hand-held manual surgical instrument designed to cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use. It is comprised of two pivoted shearing blades with finger and thumb ring-handles (i.e., not pinch-grip design) whereby the shearing action is directly adjacent to the handles (i.e., not alligator or endoscopic design). It is made of metal and available in a variety of blade designs; the blades may have carbide inserts along the cutting edges. 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
04049047003205GimmiGimmi GmbHHDK2025-04-22
04049047003212GimmiGimmi GmbHHDK2025-04-22
04049047003229GimmiGimmi GmbHHDK2025-04-22
04049047679844GimmiGimmi GmbHHDK2025-04-22
04049047679851GimmiGimmi GmbHHDK2025-04-22
00840183526207BR Surgical, LLCBR Surgical, LLCHDK2024-03-28
G586OB6441260Novo SurgicalNOVO SURGICAL, INC.HDK2023-12-18
G586OB96442290Novo SurgicalNOVO SURGICAL, INC.HDK2023-12-18
00190776050337AvalignAvalign Technologies, Inc.HDK2023-09-28
00190776250621AvalignAvalign Technologies, Inc.HDK2023-09-28
07898506853847QuinelatoSchobell Industrial LtdaHDK2023-07-11
00190776250669AvalignAVALIGN TECHNOLOGIES, INC.HDK2023-06-23
00840183513542BR Surgical, LLCBR Surgical, LLCHDK2023-04-14
54026704792103PILLINGTELEFLEX INCORPORATEDHDK2022-12-08
00842331161261Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00842331167171Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00887482024171Symmetry Surgical®SYMMETRY SURGICAL INC.HDK2022-09-21
00887482039465Symmetry Surgical®SYMMETRY SURGICAL INC.HDK2022-09-21
00887482039472Symmetry Surgical®SYMMETRY SURGICAL INC.HDK2022-09-21
00887482018644Symmetry Surgical®SYMMETRY SURGICAL INC.HDK2022-08-23
00190660157180Ambler SurgicalAMBLER SURGICAL CORP.HDK2021-01-04
00190660157197Ambler SurgicalAMBLER SURGICAL CORP.HDK2021-01-04
04046826070595MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDK2020-09-24
04046826070618MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDK2020-09-24
04046955086597AESCULAPAESCULAP, INC.HDK2020-05-06
04038653042470AESCULAPAesculap AGHDK2020-04-20
04038653042487AESCULAPAesculap AGHDK2020-04-20
H8343021900Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDK2018-09-18
H8343021950Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDK2018-09-18
24026704514933PILLINGTELEFLEX INCORPORATEDHDK2018-09-15