FDA.reportPublic FDA data

N/A

Primary DI
00841036027551
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
09-0178
Catalog number
09-0178
Published
2018-08-22
Public version status
Update
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
HTXRONGEUR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036027551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036027551008410360275518410360275510841036027551

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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
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
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00888233016902N/ASP-2482SP-24822020-06-16
008882330182272.0MM SYSTEMSP-2640SP-26402020-06-16
00888233078986VENAPAX XLVPX40002025-03-31
00888233012430N/ASP-1634SP-16342020-06-16
00888233013680CMF SYSTEMSP-1883SP-18832020-06-16
00888233013703CMF SYSTEMSP-1884SP-18842020-06-16
00888233013727CMF SYSTEMSP-1885SP-18852020-06-16
00888233013741CMF SYSTEMSP-1886SP-18862020-06-16
00888233025348LactoSorb SystemSP-1688SP-16882020-06-16
00888233025355LactoSorb SystemSP-1689SP-16892020-06-16
00888233025362LactoSorb SystemSP-1690SP-16902020-06-16
00888233025379LactoSorb System - MandibularSP-1778SP-17782020-06-16
00888233025386LactoSorb System - MandibularSP-1779SP-17792020-06-16
00888233025645LactoSorb System - MandibularSP-1944SP-19442020-06-16
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055250189Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810055250202Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450509Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450516Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450547Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450554Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450561Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450578Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450585Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450592Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450608Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450615Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450622Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450639Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450646Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450653Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450660Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451322Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451339Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451346Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451353Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451360Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451377Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451384Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451391Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451407Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451414Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451520Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451544Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451551Surgical DesignSurgical Design, Inc.HTX2026-05-23