FDA.reportPublic FDA data

Rotatable Biopsy Forceps, 2mm Spoon, 12cm WL

Primary DI
00810009463054
Brand
Rotatable Biopsy Forceps, 2mm Spoon, 12cm WL
Company
MIZUHO AMERICA, INC.
Model
07-829-11
Device description
Actuated Holder
Published
2023-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810009463054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810009463054008100094630548100094630540810009463054

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
877624940
Device count
1
Premarket exempt
true
Lot or batch
true
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
00810009465348Papevero Speculum 70mm 99-200-172023-01-23
00810009465355Trapezoidal Speculum 80mm down 99-200-182023-01-23
00810009465362Multi-hole atraumatic suction 9fr99-400-212022-12-05
00810009465393Osteotome, 8mm Tip, 6.5cm WL99-400-432022-12-02
00810009465416Periosteal Elevator, Straight, 12mm Tip, 7.5cm WL99-400-452022-12-02
00810009465492Tenotomy Scissors, Straight Jaw, Ring Handle, Thin Blades, 11cm99-600-332022-11-17
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275136Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275143Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275280Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275310Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275334Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275358Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275440Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275471Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275495Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275600Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275723Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275846Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275938Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275976Intrace USAPILOTIS TECH LLCGEN2026-07-03
00860015282088Intrace USAPILOTIS TECH LLCGEN2026-07-03
00190776421656MillenniumAvalign Technologies, Inc.GEN2026-06-23
00810055258512Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258543Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258550Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258567Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.GEN2026-06-22
05060212051196Adson Non-Toothed Forceps 120mmDTR MEDICAL LIMITEDGEN2026-06-10
05060212051202Adson Toothed Forceps 120mmDTR MEDICAL LIMITEDGEN2026-06-10
05060411980822Allis Tissue Forceps, 3:4 teeth, 160mmDTR MEDICAL LIMITEDGEN2026-06-10