FDA.reportPublic FDA data

EAR HOOK

Primary DI
B974EH1000S03
Brand
EAR HOOK
Company
DR.FRIGZ INTERNATIONAL(PVT)LTD,
Model
LILIE EAR HOOK
Catalog number
EH1000S
Device description
"LILIE EAR HOOK 18CM (7"") 1MM BALL, 90 DG"
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
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B974EH1000S03PrimaryHIBCC0

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
Length18Centimeter

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
00190776433093MillenniumAvalign Technologies, Inc.LRC2026-10-01
00190776432539MillenniumAvalign Technologies, Inc.LRC2026-09-28
00190776432263MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776432270MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776431440MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776432140MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776428020MillenniumAvalign Technologies, Inc.LRC2026-08-27
00190776428174MillenniumAvalign Technologies, Inc.LRC2026-08-27
00844505014762BONE WAX APPLICATORGrace Medical, Inc.LRC2026-08-27
00190776427566MillenniumAvalign Technologies, Inc.LRC2026-08-26
04054462913633evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913732evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913763evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913794evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913824evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913831evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913855evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913893evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914005evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914012evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914036evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914067evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914074evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914081evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914098evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914104evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914111evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914142evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914203evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914234evonosevonos GmbH & Co. KGLRC2026-08-25