FDA.reportPublic FDA data

Novo Surgical

Primary DI
00842331191398
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E7212-46
Catalog number
E7212-46
Device description
"schuknecht wire crimper, 6.0 mm smooth jaws, shaft 3"" (75.0 mm), 5-1/8"" (13.0 cm)"
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNNCRIMPER, WIRE, ENT, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNNCrimper, Wire, Ent, Non-SterileEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331191398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331191398008423311913988423311913980842331191398

GMDN Terms#

Term, Definition table
TermDefinition
ENT wire crimperA hand-held manual surgical instrument designed to bend wire directly in the cavities of the ears, nose, or throat. It is typically a straight or curved forceps-like instrument with a terminal end appropriately configured to manipulate wires in the cavities of the ears, nose, or throat. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)860-6686info@novosurgical.com

Regulatory Flags#

DUNS number
033029433
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G586N6863510Novo SurgicalN6863-51N6863-512023-12-18
G586N6863530Novo SurgicalN6863-53N6863-532023-12-18
G586N6863540Novo SurgicalN6863-54N6863-542023-12-18
G586N6863550Novo SurgicalN6863-55N6863-552023-12-18
G586N6863580Novo SurgicalN6863-58N6863-582023-12-18
G586N6863590Novo SurgicalN6863-59N6863-592023-12-18
G586N98831250Novo SurgicalN98831-25N98831-252023-12-18
00842331174377Novo Surgical Inc. N3807-12N3807-122022-11-14
00842331153556Novo Surgical Inc. N6863-52N6863-522022-11-12
00842331165771Novo Surgical Inc. N6863-56N6863-562022-11-13
00842331169717Novo Surgical Inc. N6863-57N6863-572022-11-13
00842331170836Novo Surgical Inc. N3807-13N3807-132022-11-13
00842331194023Novo Surgical Inc. OP7195-242023-12-07
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
G586NS80292210Novo SurgicalNS80-2922-1NS80-2922-12025-05-19
G586N8810500Novo SurgicalN8810-502025-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613028862MSI Precision Specialty InstrumentsMed Saver, Inc.NNN2025-08-01
00840183527457BR Surgical, LLCBR Surgical, LLCNNN2024-11-26
00888515227378BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.NNN2024-02-28
G586E7212440Novo SurgicalNOVO SURGICAL, INC.NNN2023-12-18
G586E7212450Novo SurgicalNOVO SURGICAL, INC.NNN2023-12-18
00190776318871MillenniumAvalign Technologies, Inc.NNN2023-11-13
00190776043605AvalignAvalign Technologies, Inc.NNN2023-09-28
00190776318826MILLENNIUMAvalign Technologies, Inc.NNN2023-09-28
00190776318840MILLENNIUMAvalign Technologies, Inc.NNN2023-09-28
14026704804228PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
14026704804235PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
14026704804273PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
54026704804233PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
54026704804226PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
54026704804271PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
00842331174704Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-14
00842331177682Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-14
00842331186219Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-14
00842331146206Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-11
00887482112908Symmetry HouseASPEN SURGICAL PRODUCTS, INC.NNN2022-09-28
00887482113004Symmetry ScheerASPEN SURGICAL PRODUCTS, INC.NNN2022-09-28
00190776043575AvalignAvalign Technologies, Inc.NNN2021-11-03
00190776043582AvalignAvalign Technologies, Inc.NNN2021-11-03
00190776043612AvalignAvalign Technologies, Inc.NNN2021-11-03
00190776188658MillenniumAvalign Technologies, Inc.NNN2021-11-01
00190660056643Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07
00190660063733Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07
00190660063740Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07
00190660072605Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07
00190660072797Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07