FDA.report

Novo Surgical Inc.

Primary DI
00842331154973
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
OB6386-12
Catalog number
OB6386-12
Device description
sims (thomas) curette, blunt, 11" (27.9 cm), malleable, size #1, 7.0 mm
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
HCYCurette, Uterine

Product Code Classifications

CodeDeviceSpecialtyClass
HCYCurette, UterineObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842331154973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331154973008423311549738423311549730842331154973

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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G5862562529S0Novosurgical25625-29S2025-01-02
G586N6969090NovosurgicalN6969-092025-01-02
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G586N6971730NovosurgicalN6971-732025-01-02
G586N6972700NovosurgicalN6972-702025-01-02
G586NS47110610NovosurgicalNS47-1106-12025-01-02

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