FDA.reportPublic FDA data

EAR HOOK

Primary DI
B974EH100DS0
Brand
EAR HOOK
Company
DR.FRIGZ INTERNATIONAL(PVT)LTD,
Model
LILIE EAR HOOK
Catalog number
EH100DS
Device description
LILIE EAR HOOK 17.4 CM, 1 MM BALL, 90 DEGREE, SATIN, DELICATE
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
B974EH100DS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, single-useA 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 single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length17.4Centimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
645680125
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
B974122000FORCEPSPEAN FORCEPS122002022-11-22
B9742370FORCEPSSPONGE FORCEPS2372022-11-22
B974818900FORCEPSPEAN FORCEPS818902022-11-22
B974AF25720S0EAR FORCEPSMICRO ALLIGATOR FORCEPSAF25720S2022-11-22
B974ATF8PAS0FORCEPSALLIS TISSUE FORCEPSATF8PAS2022-11-22
B974CF818000FORCEPSCRILE FORCEPSCF818002022-11-22
B974CF818100FORCEPSCRILE FORCEPSCF818102022-11-22
B974CK80400FORCEPSKELLY FORCEPSCK80402022-11-22
B974EA5850FORCEPSPEAN FORCEPSEA5852022-11-22
B974EA6000FORCEPSSPONGE FORCEPS EA6002022-11-22
B974EA6100FORCEPSALLIS TISSUE FORCEPSEA6102022-11-22
B974EA610S02FORCEPSALLIS TISSUE FORCEPSEA610S2022-11-22
B974EA8560FORCEPSALLIS TISSUE FORCEPSEA8562022-11-22
B974FS95000FORCEPSSPONGE FORCEPSFS9502022-11-22
B974IF10560FORCEPSLOWA PUNCTURING FORCEPSIF10562022-11-22
B974IF2250FORCEPSUMBILICAL FORCEPSIF2252022-11-22
B974MHS1020HAEMOSTATIC FORCEPSMOSQUITO FORCEPSMHS1022022-11-22
B974MHS102FS0FORCEPSMOSQUITO FORCEPSMHS102FS2022-11-22
B974MHS102L0FORCEPSMOSQUITO FORCEPSMHS102L2022-11-22
B974MHS102S0FORCEPSMOSQUITO FORCEPSMHS102S2022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G141520422030Carnegie Surgical LLCCarnegie Surgical LLCGDG2026-09-30
G141520422040Carnegie Surgical LLCCarnegie Surgical LLCGDG2026-09-30
00724995267896Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-25
00190776432379MillenniumAvalign Technologies, Inc.GDG2026-09-24
00190776432423MillenniumAvalign Technologies, Inc.GDG2026-09-24
00724995267483Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267490Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267506Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267513Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267520Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267544Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267551Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267568Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267575Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267582Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267599Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267605Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267612Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267629Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00850088713954PRINCETONPrinceton Medical Group, Inc.GDG2026-09-22
00190776431099MillenniumAvalign Technologies, Inc.GDG2026-09-21
B033K941409" Nerve HookKapp Surgical Instrument Co.GDG2026-08-27
00810158215955PRINCETONPrinceton Medical Group, Inc.GDG2026-08-25
10850067560323MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560330MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560347MaxRetractSurgical Principals, IncGDG2026-08-25
00190776419660MillenniumAvalign Technologies, Inc.GDG2026-08-23
00190776417161MillenniumAvalign Technologies, Inc.GDG2026-08-19
00190776417079MillenniumAvalign Technologies, Inc.GDG2026-08-18
00190776422219MillenniumAvalign Technologies, Inc.GDG2026-07-31