FDA.reportPublic FDA data

Rotatable Microscissors, Angled Jaw, Single Shaft Handle, Long Blades, 16cm WL

Primary DI
00810009463306
Brand
Rotatable Microscissors, Angled Jaw, Single Shaft Handle, Long Blades, 16cm WL
Company
MIZUHO AMERICA, INC.
Model
07-829-50MA
Device description
Actuated Cutting
Published
2022-11-17
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
false

Product Codes#

Code, Name table
CodeName
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810009463306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810009463306008100094633068100094633060810009463306

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
877624940
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810009460008Micro Dilator Forceps, Bayonet, Angled Tip, 50mm WL07-868-09MA2025-12-09
00810009460213Micro Dilator Forceps, Bayonet, Straight Tip, 35mm WL07-868-07MA2025-12-09
00810009466604Micro Dilator Forceps, Bayonet, Straight Tip, 50mm WL07-868-08MA2025-12-09
00810009465331Cottle Speculum, 110mm flared tip 99-200-092023-01-23
00810009460060Ring Curette, Donut Style, 3mm, Offset, 15cm WL10198MA2023-08-15
00810009460152LawtonElite Microscissors Bayonet, Reposable, Curved Right Blades, 10cm WL10294MA2023-08-15
00810009460169LawtonElite Microscissors Bayonet, Reposable, Curved Left Blades, 10cm WL10295MA2023-08-15
00810009460541Yasargil Tumor Forceps, Bayonet, 5mm Serrated Spoon, 9cm WL02-082-452023-08-15
00810009460824Yasargil Forceps, Bayonet, 11.5cm WL07-110-102023-08-15
00810009461180Ring Curette, Donut Style, 3mm, 125 Degrees Up, 15cm WL10296MA2023-08-15
00810009462132Sizer Dissector, Straight07-823-012023-08-15
00810009463054Rotatable Biopsy Forceps, 2mm Spoon, 12cm WL07-829-112023-08-15
00810009463580Sugita AVM Clip Case07-932-002023-08-15
00810009463801Biopsy Forceps, 1mm Spoon, 10cm WL07-869-022023-08-15
00810009464129Tapered Suction Tube, One Piece, 9Fr, 11cm WL07-960-09L2023-08-15
00810009464303Head Frame Case07-980-002023-08-15
00810009464310Radiolucent Head Frame Case07-980-00R2023-08-15
00810009465867Evans Endonasal Set Tray10293MA2023-08-15
00810009466017Tapered Suction Tube, 6Fr, Malleable, 13.3cm WL10224MA2023-08-15
00810009466024Ring Curette, Donut Style, 3mm, Curved 45 Degrees Lateral, 15cm WL10223MA2023-08-15

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