FDA.report

Novo Surgical Inc.

Primary DI
00842331156830
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
N93064-65
Catalog number
N93064-65
Device description
zenith Bruns Spinal Fusion Curette, oval, straight, size 4, 9"" (23.0 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
EMKCurette, Surgical, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842331156830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331156830008423311568308423311568300842331156830

GMDN Terms

TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. 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

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G586NS720155800Novo Surgical IncNS720-1558-0NS720-1558-02025-09-15
00842331192968Novo Surgical IncG1911-38IG-NS2023-08-21
G586N8810500Novo SurgicalN8810-502025-05-19
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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
00348783007831Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-03-17
B382SD9162110970Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD916211098Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD9162111000Surgical DirectSurgical Direct, Inc.EMK2026-03-02
G1493800400TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493800501TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493806204TBS DentalACME ENTERPRISE.EMK2026-03-02
G149TBSBP03TBS DentalACME ENTERPRISE.EMK2026-03-02
B382SD915585140Surgical DirectSurgical Direct, Inc.EMK2026-02-25
B382SD48713950600Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48800200Surgical DirectSurgical Direct, Inc.EMK2026-02-04
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B382SD915570050Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915579000Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915580070Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155911020Surgical DirectSurgical Direct, Inc.EMK2026-02-04
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00841336108653Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
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