FDA.reportPublic FDA data

Integra®

Primary DI
10381780076919
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3712028
Catalog number
3712028
Device description
"Integra® Hajek-Kofler Antrum Punch, 5-1/2"", 45° Backward Bite"
Published
2018-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAWPUNCH, ANTRUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAWPunch, AntrumEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780076919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007691910381780076919

GMDN Terms#

Term, Definition table
TermDefinition
Adenoid punch forcepsA hand-held manual surgical instrument with a cutting/biting action intended to be used for excising adenoid tissue (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy (adenectomy). It is a metallic alligator-forceps-like instrument, often with a curved shaft, and with a distal mechanism designed to bite/punch adenoid tissue when the handles are squeezed together. It is not intended for cutting bone (i.e., not a rongeur). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle45degree
Device Size Text, specify0
Device Size Text, specify0

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
1
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
00757770508570Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508587Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508594Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508600Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508631Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508648Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508662Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00840183530730BR Surgical, LLCBR Surgical, LLCKAW2025-08-26
00840183530747BR Surgical, LLCBR Surgical, LLCKAW2025-08-26
00194613011499MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613029326MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613029364MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613047214MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613047221MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613061739MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081393MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081447MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081508MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081560MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613085568MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613088842MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613091507MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613094720MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613095062MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613102104MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613102111MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613106171MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613123765MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00757770508563Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31
00757770508624Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31