FDA.reportPublic FDA data

Instrumentarium

Primary DI
00810055471577
Brand
Instrumentarium
Company
Société Chirurgicale Instrumentarium Inc
Model
L.70.902
Published
2021-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GDGHook, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055471577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055471577008100554715778100554715770810055471577

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. 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

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