FDA.reportPublic FDA data

Integra®

Primary DI
10381780086147
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3734097
Catalog number
3734097
Device description
Sage Cut Wires, Size 7
Published
2018-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBZSNARE, TONSIL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBZSnare, TonsilEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780086147PrimaryGS10
00381780086140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178008614710381780086147
00381780086140003817800861403817800861400381780086140

GMDN Terms#

Term, Definition table
TermDefinition
Tonsil snareA manual surgical instrument inserted into the oral cavity to remove the tonsils 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 root of the tonsil 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
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
12
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780544319Codman® CereLink®826820P826820P2025-03-12
10381780524106CODMAN® BACTISEAL®NS0344NS03442024-11-20
10381780525370CODMAN® BACTISEAL®NS5091NS50912024-11-20
10381780521280CODMAN® CERTAS® Plus828807PL82-8807PL2024-11-20
10381780535805CODMAN® CERTAS® Plus828813PL82-8813PL2024-11-20
10381780535843CODMAN® CERTAS® Plus828823PL82-8823PL2024-11-20
10381780535867CODMAN® CERTAS® Plus828827PL82-8827PL2024-11-20
10381780536970CODMAN® BACTISEAL®82174582-17452024-11-20
10381780536987CODMAN® BACTISEAL®82307282-30722024-11-20
10381780536994CODMAN® BACTISEAL®82307382-30732024-11-20
10381780537007CODMAN® BACTISEAL®82307482-30742024-11-20
10381780537014CODMAN® BACTISEAL®82174982-17492024-11-20
10381780537021CODMAN® BACTISEAL®82175082-17502024-11-20
10381780537038CODMAN® BACTISEAL®82308782-30872024-11-20
10381780537045CODMAN® BACTISEAL®82308882-30882024-11-20
10381780537052CODMAN® BACTISEAL®NS0338NS03382024-11-20
10381780537069CODMAN® BACTISEAL®NS0339NS03392024-11-20
10381780537076CODMAN® BACTISEAL®NS0340NS03402024-11-20
10381780537083CODMAN® BACTISEAL®NS0343NS03432024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®NS5048NS50482024-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613011550MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00194613048983MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00194613090739MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00194613097950MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00194613121037MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00194613121044MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-08-01
00757770413003Bausch + LombBausch & Lomb IncorporatedKBZ2025-07-29
00757770420629Bausch + LombBausch & Lomb IncorporatedKBZ2025-07-29
00757770433995Bausch + LombBausch & Lomb IncorporatedKBZ2025-07-29
04049047127918GimmiGimmi GmbHKBZ2025-05-21
04049047127925GimmiGimmi GmbHKBZ2025-05-21
00194613104566MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-03-21
00887482030059Symmetry Surgical®SYMMETRY SURGICAL INC.KBZ2024-08-15
00887482030066Symmetry Surgical®SYMMETRY SURGICAL INC.KBZ2024-08-15
00887482030073Symmetry Surgical®SYMMETRY SURGICAL INC.KBZ2024-08-15
00887482049204Symmetry Surgical®SYMMETRY SURGICAL INC.KBZ2024-08-15
00887482122891Symmetry Surgical®SYMMETRY SURGICAL INC.KBZ2024-08-15
00887482122914Symmetry Surgical®SYMMETRY SURGICAL INC.KBZ2024-08-15
00887482122938Symmetry Surgical®SYMMETRY SURGICAL INC.KBZ2024-08-15
00887482192740Symmetry Surgical®SYMMETRY SURGICAL INC.KBZ2024-08-15
00887482192856Symmetry Surgical®SYMMETRY SURGICAL INC.KBZ2024-08-15
00888515248403BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KBZ2024-02-28
00888515248489BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KBZ2024-02-28
00888515248496BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KBZ2024-02-28
00888515248519BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KBZ2024-02-28
00888515248540BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KBZ2024-02-28
00888515248557BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KBZ2024-02-28
00842331195518Novo SurgicalNOVO SURGICAL, INC.KBZ2023-12-18
G586E8361210Novo SurgicalNOVO SURGICAL, INC.KBZ2023-12-18
G586E8361220Novo SurgicalNOVO SURGICAL, INC.KBZ2023-12-18