FDA.reportPublic FDA data

NEEDLE

Primary DI
B974HRP000DC0
Brand
NEEDLE
Company
DR.FRIGZ INTERNATIONAL(PVT)LTD,
Model
HOUSE ROSEN NEEDLE
Catalog number
HRP000DC
Device description
HOUSE ROSEN NEEDLE SLIGHTLY CVD OVER ALL LENGTH 6-1/2 INCH 16.5 CM (DELICATE TIP)
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
KADElevator, Ent

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B974HRP000DC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, single-useA cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.5Inch

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
00757770683567Bausch + LombBausch & Lomb IncorporatedKAD2026-05-11
09348811101655INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-04-24
09348811102522INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-04-24
09348811101433INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-03-18
04046826112790MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAD2026-03-04
00190776415945MillenniumAvalign Technologies, Inc.KAD2026-02-06
00757770425143Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
00757770636822Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
09348811101587INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-28
00810207783039Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783046Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783053Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783060Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783077Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783084Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783091Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783107Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783114Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783121Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783138Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783145Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783152Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
09348811101501INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-24
09348811101532INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-24
00757770636341Bausch + LombBausch & Lomb IncorporatedKAD2025-11-15
04250381888438Hurd elevator/retractorSpiggle & Theis Medizintechnik GmbHKAD2025-10-06
04250676733900Sewall antrum elevatorSpiggle & Theis Medizintechnik GmbHKAD2025-10-05
04250381860588Weber elevator, double endedSpiggle & Theis Medizintechnik GmbHKAD2025-09-25
04250381852057Williger elevatorSpiggle & Theis Medizintechnik GmbHKAD2025-09-24
04250676714497Langenbeck-Quervain elevatorSpiggle & Theis Medizintechnik GmbHKAD2025-09-24