FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331189456
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7321-21
Catalog number
E7321-21
Device description
"krause ear snare, includes 1 package of 12 snare wires, 7 1/8"" (18.0 cm)"
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZDSnare, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZDSnare, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331189456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331189456008423311894568423311894560842331189456

GMDN Terms#

Term, Definition table
TermDefinition
Ear snareA hand-held manual surgical instrument intended to be inserted through the outer ear canal or through a surgical incision in the ear to remove tissue, typically tumorous or damaged tissue, from the ear during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1877-860-6686info@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
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20757770457650Bausch + LombBausch & Lomb IncorporatedJZD2026-04-30
20757770457667Bausch + LombBausch & Lomb IncorporatedJZD2026-04-30
20757770457674Bausch + LombBausch & Lomb IncorporatedJZD2026-04-30
00757770412914Bausch + LombBausch & Lomb IncorporatedJZD2025-08-04
00842962145937HNM MedicalHNM STAINLESS, LLC.JZD2024-03-08
00888515231061BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JZD2024-02-28
00888515231085BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JZD2024-02-28
00190776221171AvalignAvalign Technologies, Inc.JZD2023-06-23
00190660173708Ambler SurgicalAMBLER SURGICAL CORP.JZD2021-01-04
00190660173715Ambler SurgicalAMBLER SURGICAL CORP.JZD2021-01-04
00190660173722Ambler SurgicalAMBLER SURGICAL CORP.JZD2021-01-04
04046826102272MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826102289MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
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04046826276140MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826276157MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
B351B699000BEARMytamed, Inc.JZD2020-08-20
B351B699010BEARMytamed, Inc.JZD2020-07-13
04038653176359AESCULAPAesculap AGJZD2020-04-22
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04038653341269AESCULAPAesculap AGJZD2020-04-22