FDA.report

Novo Surgical Inc.

Primary DI
00842331136627
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
N8755-13
Catalog number
N8755-13
Device description
boehler wire & pin extractor, 160.0 mm wide x 90.0 mm long
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
KQZComponent, Traction, Non-Invasive

Product Code Classifications

CodeDeviceSpecialtyClass
KQZComponent, Traction, Non-InvasiveOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842331136627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331136627008423311366278423311366270842331136627

GMDN Terms

TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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

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00610570001712100 FT. 3/16" TRACTION CORDBird & Cronin, LLCKQZ2022-08-20
006105700017501500 FT. 3/16" TRACTION CORDBird & Cronin, LLCKQZ2022-08-20
00610570006588BUCKS BOOT XSBird & Cronin, LLCKQZ2022-08-20
00610570006595BUCKS BOOT SMBird & Cronin, LLCKQZ2022-08-20
00610570006601BUCKS BOOT MDBird & Cronin, LLCKQZ2022-08-20
00610570006618BUCKS BOOT LGBird & Cronin, LLCKQZ2022-08-20
00610570006649BUCKS BOOT UNIV CLSD-COMPLETEBird & Cronin, LLCKQZ2022-08-20
00610570006656DISPOSABLE PAD-UNIVERSAL BOOTBird & Cronin, LLCKQZ2022-08-20
00610570006663SADDLE FOR UNIV BUCKS TRACTIONBird & Cronin, LLCKQZ2022-08-20
00610570011810DISKARD HEAD HALTERBird & Cronin, LLCKQZ2022-08-20
00610570011858DELUXE HEAD HALTER UNIV BLACKBird & Cronin, LLCKQZ2022-08-20
00610570012503SPREADER BAR 12" NOTCHEDBird & Cronin, LLCKQZ2022-08-20
0061057001260220# WATER WEIGHT BAGBird & Cronin, LLCKQZ2022-08-20
00610570068951EXERCISE BAND ANCHOR STRAPS 10/PKBird & Cronin, LLCKQZ2022-08-20
07290015711302D.B.S. Dynamic Brace SystemMEDITRAC LTD.KQZ2022-07-25
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00810075281194Bone FoamBONE FOAM, INC.KQZ2022-05-22