FDA.reportPublic FDA data

Instrumentarium

Primary DI
00810055471188
Brand
Instrumentarium
Company
Société Chirurgicale Instrumentarium Inc
Model
S.50.630
Published
2020-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KAEForceps, Ent

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055471188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055471188008100554711888100554711880810055471188

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203088166
Device count
1
Premarket exempt
true
No natural rubber latex
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
09348811103796INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104236INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104595INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104908INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104915INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104953INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105653INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105707INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172099INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172112INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-18
G04371902F0BEARBear-Ent, LLCKAE2026-02-12
09348811105400INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-21
09348811129024INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-19
08906039316018OSSEOUS Titanium-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316025OSSEOUS Fluoroplastic-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316032OSSEOUS Stapes Prosthesis Crimping ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316049OSSEOUS Tilley's Nasal Dressings Forceps EON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039319699OSSEOUS Micro Alligator Ear ForcepesEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
G586NS80152710Novo SurgicalNOVO SURGICAL, INC.KAE2024-02-22
07898506842704QuinelatoSchobell Industrial LtdaKAE2023-01-09
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