FDA.reportPublic FDA data

Kerrison rongeur

Primary DI
04946329119862
Brand
Kerrison rongeur
Company
MIZUHO CORPORATION
Model
02-200-03
Catalog number
02-200-03
Device description
Kerrison rongeur, upward, 40 degree, 200mm(L)x3mm(W)
Published
2022-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBBRongeur, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBBRongeur, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04946329119862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04946329119862049463291198624946329119862

GMDN Terms#

Term, Definition table
TermDefinition
Bone cutting forceps, reusableA strongly constructed, hand-held, surgical instrument used for cutting posterior rib ends and bone tissue during a surgical procedure. It typically has very strong, sharp, angled cutting blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the blades so that they cut entirely through the bone. It is available in various sizes and is made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length203Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999regulatory@mizuho.co.jp

Regulatory Flags#

DUNS number
690677802
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
04946329173932Operating Table VACB-3006B08-041-2008-041-202025-09-05
04946329308259Operating Table VACB-3006B Type150S08-055-7508-055-752025-09-05
04946329385847Narrow head section08-075-0008-075-002025-09-05
04946329385854Narrow head section08-083-6908-083-692025-09-05
04946329385861Narrow head section08-083-7008-083-702025-09-05
04946329404555Operating Table MST-7300BX18-045-1418-045-142025-09-05
04946329443066Side Rail Clamp (18 mm)08-110-1808-110-182025-06-26
04946329404234Short Boot Extender18-070-5018-070-502025-06-10
04946329416725SUGITA TITANIUM ANEURYSM CLIP II17-002-4017-002-402025-04-25
04946329416732SUGITA TITANIUM ANEURYSM CLIP II17-002-4117-002-412025-04-25
04946329416749SUGITA TITANIUM ANEURYSM CLIP II17-002-4217-002-422025-04-25
04946329416756SUGITA TITANIUM ANEURYSM CLIP II17-002-4317-002-432025-04-25
04946329416763SUGITA TITANIUM ANEURYSM CLIP II17-002-4417-002-442025-04-25
04946329385519Operating Table MOT-VS70018-042-1118-042-112024-11-06
04946329385526Operating Table MOT-VS70018-042-2218-042-222024-11-06
04946329385533Operating Table MOT-VS70018-042-2318-042-232024-11-06
04946329385564Operating Table MOT-VS70018-042-6118-042-612024-11-06
04946329385571Operating Table MOT-VS70018-042-5218-042-522024-11-06
04946329385588Operating Table MOT-5602BW18-042-5318-042-532024-11-06
04946329395310Operating Table MST-7300BX18-042-0218-042-022024-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811112484INKAThe Trustee for KAISER FAMILY TRUSTKBB2026-01-28
09348811146052INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-12-01
09348811172921INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-12-01
09348811145970INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-11-27
09348811172914INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-11-27
00757770404759Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770407071Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770411979Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770425396Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770428632Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770430925Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770469475Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00190776407056MillenniumAvalign Technologies, Inc.KBB2025-07-28
08403207006042Anmuth Medical InternationalAnmuth Medical International, LLCKBB2025-01-24
08403207006059Anmuth Medical InternationalAnmuth Medical International, LLCKBB2025-01-24
00842331191404Novo SurgicalNOVO SURGICAL, INC.KBB2023-12-18
G586E7373630Novo SurgicalNOVO SURGICAL, INC.KBB2023-12-18
00190776044817AvalignAvalign Technologies, Inc.KBB2023-11-13
00190776225421AvalignAvalign Technologies, Inc.KBB2023-11-13
00190776044824AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776044831AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776044848AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776048334AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776048600AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776221102AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776320492MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28
00190776320508MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28
00190776320515MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28
00190776320522MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28
00190776325336MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28