FDA.reportPublic FDA data

Instrumentarium

Primary DI
00810055472321
Brand
Instrumentarium
Company
Société Chirurgicale Instrumentarium Inc
Model
S.50.90150.LL
Published
2021-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KTFPunch, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTFPunch, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055472321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055472321008100554723218100554723210810055472321

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203088166
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055470136InstrumentariumL.71.3252020-08-24
00810055470174InstrumentariumL.71.3302020-08-24
00810055471805InstrumentariumL.71.210.H2021-08-11
00810055471812InstrumentariumL.71.2112021-08-11
00810055471829InstrumentariumL.71.211.H2021-08-11
00810055471836InstrumentariumL.71.2152021-08-11
00810055471843InstrumentariumL.71.2252021-08-11
00810055471850InstrumentariumL.71.315.45.302021-08-11
00810055472000InstrumentariumL.71.997312021-08-11
00810055472017InstrumentariumL.71.997342021-08-11
00810055472024InstrumentariumL.72.2112021-08-11
00810055471324InstrumentariumL.70.2102021-01-13
00810055471331InstrumentariumL.70.2112021-01-13
00810055471348InstrumentariumL.70.2152021-01-13
00810055471355InstrumentariumL.70.2252021-01-13
00810055471362InstrumentariumL.70.3252021-01-13
00810055471379InstrumentariumL.70.3302021-01-13
00810055471096InstrumentariumL.99.00036262020-09-15
00810055470914InstrumentariumL.72.3152020-09-14
00810055470938InstrumentariumL.72.3252020-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417871MillenniumAvalign Technologies, Inc.KTF2026-03-11
04250676717351Kerrison rongeurSpiggle & Theis Medizintechnik GmbHKTF2025-09-25
00194613029340MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036331MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036355MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036379MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036386MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036393MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613111533MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613123741MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00190776402624MillenniumAvalign Technologies, Inc.KTF2025-06-24
00190776402433MillenniumAvalign Technologies, Inc.KTF2025-06-23
00192896121614Circular Cutting PunchSONTEC INSTRUMENTS, INC.KTF2025-06-06
00190776394943MillenniumAvalign Technologies, Inc.KTF2025-05-08
00194613029395MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036324MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036348MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036362MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613082239MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613108045MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00192896120945Ostrum Antrum PunchSONTEC INSTRUMENTS, INC.KTF2024-12-10
00190776384913MillenniumAvalign Technologies, Inc.KTF2024-08-26
00192896119000Antrum PunchSONTEC INSTRUMENTS, INC.KTF2024-08-26
00192896119024Circular Cutting PunchSONTEC INSTRUMENTS, INC.KTF2024-08-26
00887482118801Symmetry CarleyASPEN SURGICAL PRODUCTS, INC.KTF2024-08-20
00888515134003BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242135BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242142BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242173BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515243507BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28