FDA.report

NEEDLE

Primary DI
B974HRP100C0
Brand
NEEDLE
Company
DR.FRIGZ INTERNATIONAL(PVT)LTD,
Model
HOUSE ROSEN NEEDLE
Catalog number
HRP100C
Device description
HOUSE ROSEN NEEDLE SLIGHTLY CVD OVER ALL LENGTH 6-1/2 INCH 16.5 CM (REGULAR TIP)
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KADElevator, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KADElevator, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B974HRP100C0PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Length6.5Inch

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
645680125
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B974111310SCISSORSTENOTOMY SCISSORS111312022-11-22
B974111400Single Use ScissorEPISIOTOMY SCISSORS111402022-11-22
B974122000FORCEPSPEAN FORCEPS122002022-11-22
B974132420FORCEPSLORNA TOWEL FORCEPS132422022-11-22
B974132430FORCEPSLORNA TOWEL FORCEPS132432022-11-22
B9741629004NEEDLE HOLDERMAYO HEGAR NEEDLE HOLDERS162902022-11-22
B9742370FORCEPSSPONGE FORCEPS2372022-11-22
B974256950EAR FORCEPSJANSEN EAR FORCEPS256952022-11-22
B9743290808NAIL NIPPERSNAIL NIPPERS 329082022-11-22
B97450524507FORCEPSDebakey Forceps5052452022-11-22
B9748112604OPERATING SCISSORSCVD 811262022-11-22
B974813100SCISSORSMAYO SCISSORS813102022-11-22
B9748148007SCISSORSSTRABISMUS SCISSORS814802022-11-22
B974814850SCISSORS STRABISMUS SCISSORS 814852022-11-22
B974818900FORCEPSPEAN FORCEPS818902022-11-22
B974AF25720S0EAR FORCEPSMICRO ALLIGATOR FORCEPSAF25720S2022-11-22
B974ATF8PAS0FORCEPSALLIS TISSUE FORCEPSATF8PAS2022-11-22
B974BES6PAS0SCISSORSEPISIOTOMY SCISSORSBES6PAS2022-11-22
B974BNH21906NEEDLE HOLDERBAUMGARTNER NEEDLE HOLDERBNH2192022-11-22
B974BTC17306TOWEL CLAMPTOWEL CLAMPBTC1732022-11-22

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