FDA.reportPublic FDA data

N/A

Primary DI
00841036024406
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
03-1700
Catalog number
03-1700
Published
2018-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00841036024406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036024406008410360244068410360244060841036024406

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
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
00841036007621N/A01-037001-03702017-04-06
00841036007638N/A01-037101-03712017-04-06
00841036008819N/A01-145501-14552017-04-11
00841036159139N/A01-037601-03762017-04-06
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMWAL305WAL3052019-06-17
00888233078986VENAPAX XLVPX40002025-03-31
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00841036054229N/A915-2055915-20552015-10-11
00841036077969N/A915-2057915-20572015-10-15
00888233005371PECTUS SYSTEM01-390701-39072020-06-17
00888233011334RIBFIX BLU SYSTEM76-000376-00032020-06-18
00888233011587RIBFIX BLU SYSTEM76-119576-11952020-06-18
008882330161311.5MM SYSTEMSP-2335SP-23352020-06-16
008882330161862.0MM SYSTEMSP-2347SP-23472020-06-16
00888233018272TRAUMAONE SYSTEMSP-3228SP-32282020-06-17
00888233022385N/ASP-3139SP-31392020-06-17
00888233018296N/ASP-32302024-09-26
00888233069342STERNALOCK EZ115.101.04115.101.042024-05-29
00888233069359STERNALOCK EZ115.102.06115.102.062024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811112323INKAThe Trustee for KAISER FAMILY TRUSTKBB2026-03-18
09348811112347INKAThe Trustee for KAISER FAMILY TRUSTKBB2026-03-18
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