FDA.report

Novo Surgical

Primary DI
G586C6681670
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
C6681-67
Catalog number
C6681-67
Device description
jacobson endarterectomy spatula, semi-sharp blade 1.0 mm x 10.0 mm, 7" (17.5 cm), angled blade
Published
2023-12-18
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
false

Related Records

Contact Domains

Product Codes

CodeName
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G586C6681670PrimaryHIBCC0

GMDN Terms

TermDefinition
Vascular spatulaA hand-held surgical instrument designed to be used within the vasculature (a blood vessel) to scrape, manipulate, and remove tissue therein. It typically made of high-grade stainless steel and consists of a flat blunt blade (no sharp edges) that is either single-ended or double-ended (a blade at either end). It is available with a variety of blade designs, e.g., curved and spoon-shaped or curved and straight. The handle can be placed proximally or be formed from its middle section and may be more prominent/serrated. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)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

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G586G311041NC0Novo SurgicalG3110-41NC2025-03-21
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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

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