FDA.report

Novo Surgical Inc.

Primary DI
00842331137488
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
N8821-39
Catalog number
N8821-39
Device description
bone hook, grip handle, sharp, 13.0 mm, 9" (23.0 cm)
Published
2022-11-10
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
KIKHook, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
KIKHook, BoneGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842331137488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331137488008423311374888423311374880842331137488

GMDN Terms

TermDefinition
Bone hookA hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. 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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G586N697206A0NovosurgicalN6972-06AN6972-05A2025-02-06
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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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