FDA.reportPublic FDA data

LACTOSORB* 1.5MM SYSTEM TEMPLATE

Primary DI
00841036076894
Brand
LACTOSORB* 1.5MM SYSTEM TEMPLATE
Company
BIOMET MICROFIXATION, INC
Model
914-2427
Catalog number
914-2427
Published
2018-09-14
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
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036076894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036076894008410360768948410360768940841036076894

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. 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
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
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
00888233077200PECTUS BLU (TM)78-808278-80822024-09-30
00888233077224PECTUS BLU (TM)78-830078-83002024-09-30
00888233077231PECTUS BLU (TM)78-835078-83502024-09-30
00888233077248PECTUS BLU (TM)78-840078-84002024-09-30
00888233077255PECTUS BLU (TM)78-845078-84502024-09-30
00888233077279PECTUS BLU (TM)78-855078-85502024-09-30
00888233028776PECTUS BLU (TM)78-001078-00102022-02-09
00888233028783PECTUS BLU (TM)78-001178-00112022-02-09
00888233028790PECTUS BLU (TM)78-001278-00122022-02-09
00888233028806PECTUS BLU (TM)78-002078-00202022-02-09
00888233028813PECTUS BLU (TM)78-003078-00302022-02-09
00888233028837PECTUS BLU (TM)78-004078-00402022-02-09
00888233028844PECTUS BLU (TM)78-005078-00502022-02-09
00888233028851PECTUS BLU (TM)78-005178-00512022-02-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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