FDA.reportPublic FDA data

Integra®

Primary DI
10381780086178
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3734104
Catalog number
3734104
Device description
"Integra® Snare Wire, 0.5 mm, 4-1/2"" Long"
Published
2018-10-24
Public version status
Update
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
KBZSNARE, TONSIL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780086178PrimaryGS10
00381780086171Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178008617810381780086178
00381780086171003817800861713817800861710381780086171

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20757770455878Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
20757770457803Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
20757770457810Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
20757770457827Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
20757770457834Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
20757770457841Bausch + LombBausch & Lomb IncorporatedKBZ2026-04-30
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 SurgicalASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482030066Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482030073Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482049204Symmetry EveASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482122891Symmetry EveASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482122914Symmetry TydingASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482122938SymmetryASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482192740Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBZ2024-08-15
00887482192856Symmetry SurgicalASPEN SURGICAL PRODUCTS, 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