FDA.reportPublic FDA data

Rotatable Biopsy Forceps, 4mm Spoon, 12cm WL

Primary DI
00810009463139
Brand
Rotatable Biopsy Forceps, 4mm Spoon, 12cm WL
Company
MIZUHO AMERICA, INC.
Model
07-829-19
Device description
Actuated Holdeer
Published
2022-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810009463139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810009463139008100094631398100094631390810009463139

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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
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

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Primary DI, Brand, Company table
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G4250601180My MedicalMy Medical Store LLCHTD2026-05-04
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G4250602980My MedicalMy Medical Store LLCHTD2026-05-04
G425310840NC0My MedicalMy Medical Store LLCHTD2026-05-04
G4254402140My MedicalMy Medical Store LLCHTD2026-05-04
G4254403120My MedicalMy Medical Store LLCHTD2026-05-04
G8142900SFPP3Garish ApparelsGARISH APPARELSHTD2026-04-28
09348811015402INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-21
09348811012678INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012722INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012913INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811013163INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811014603INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811129345INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
10649111493270Trinity Sterile, Inc.SKLAR CORPORATIONHTD2024-12-12
G586UR6201390Novo SurgicalNOVO SURGICAL, INC.HTD2024-07-23
10195327656256Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HTD2024-07-10
10195327621100Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HTD2024-02-05
G508RSCMD4700Raw Surgical CorporationRAW SURGICAL CORPORATIONHTD2023-11-19
G1413040800Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G1413040820Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G1413040840Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
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G25003004120Halsted Mosquito Forceps 12.5cm CurvedN S SURGICAL COMPANYHTD2023-01-31
G25003051180Standard Tube Forceps 18cmN S SURGICAL COMPANYHTD2023-01-30
G25003052180Foerster Sponge Forceps 18cm StraightN S SURGICAL COMPANYHTD2023-01-30
G25003001100Hartmann Mosquito Forcep 10cm StraightN S SURGICAL COMPANYHTD2023-01-28
G25003002100Hartmann Mosquito Forcep 10cm CurvedN S SURGICAL COMPANYHTD2023-01-28
G25003007120Micro Mosquito Forceps 12cm StraightN S SURGICAL COMPANYHTD2023-01-28