FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331156854
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7761-16
Catalog number
E7761-16
Device description
ballenger swivel knife, straight, 7 3/4" (19.7 cm), 5.0 mm wide
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
KTGKnife, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KTGKnife, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842331156854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331156854008423311568548423311568540842331156854

GMDN Terms

TermDefinition
Skin grafting knifeA hand-held, one-piece, manual surgical instrument designed to cut donor-site skin strips intended for grafting. It has a knife-like design with a flat broad blade and a sharp cutting edge; it is usually made of stainless steel. This device may reflect old technology. 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
00757770429301Bausch + LombBausch & Lomb IncorporatedKTG2026-02-04
04250381870433SeparatorSpiggle & Theis Medizintechnik GmbHKTG2025-09-19
04250676723192Sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676735072KnifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676718600Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-12
04250676740595Teschner sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
04250676741790Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
00190776409371MillenniumAvalign Technologies, Inc.KTG2025-08-28
00190776409388MillenniumAvalign Technologies, Inc.KTG2025-08-28
00194613056377MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613056407MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613102609MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613108700MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613108762MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613118037MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613119621MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00757770422234Bausch + LombBausch & Lomb IncorporatedKTG2025-07-29
00757770423699Bausch + LombBausch & Lomb IncorporatedKTG2025-07-29
00190776406615MillenniumAvalign Technologies, Inc.KTG2025-07-23
00190776405694MillenniumAvalign Technologies, Inc.KTG2025-07-18
00190776397647MillenniumAvalign Technologies, Inc.KTG2025-05-16
00194613047504MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056353MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056360MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056391MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613107734MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613108625MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613109226MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
G141546380150Carnegie Surgical LLCCarnegie Surgical LLCKTG2025-02-03
00840183529284BR Surgical, LLCBR Surgical, LLCKTG2025-01-03