FDA.reportPublic FDA data

1.5 LACTOSORB SYSTEM

Primary DI
00841036054861
Brand
1.5 LACTOSORB SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
915-2216
Catalog number
915-2216
Published
2015-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHBPOLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHBPolymer, Ear, Nose And Throat, Synthetic, AbsorbableEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012409000LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTSWalter Lorenz Surgical, Inc.2001-10-18NHB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036054861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036054861008410360548618410360548610841036054861

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, bioabsorbableA small, sterile, threaded rod with a slotted head used for craniofacial bone (including the maxilla and/or mandible) fracture fixation by being screwed into bone to hold plates to bone or to provide direct interfragmentary stabilization of bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Expiration date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801741044080HemaDermDavol Inc.NHB2023-10-09
00860001820898PuraGel 5mL3-D MATRIX INC.NHB2023-09-20
00860007400308PuraGel 3mL3-D MATRIX INC.NHB2023-09-20
00860007400315PuraGel 1mL3-D MATRIX INC.NHB2023-09-20
00860001820829PuraSinus 5mL3-D MATRIX INC.NHB2022-07-13
00860001820836PuraSinus 3mL3-D MATRIX INC.NHB2022-07-13
00860001820843PuraSinus 1mL3-D MATRIX INC.NHB2022-07-13
00857037006075LATERASTRYKER CORPORATIONNHB2020-01-14
00857037006013LATERASTRYKER CORPORATIONNHB2020-01-08
00857037006037LATERASTRYKER CORPORATIONNHB2020-01-08
00857037006082LATERASTRYKER CORPORATIONNHB2018-06-04
00857037006105LATERASTRYKER CORPORATIONNHB2017-09-19
00857037006921LATERAENTELLUS MEDICAL, INC.NHB2017-09-19
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10705031087996PDS PlatesEthicon Inc.NHB2017-06-14
10705031088009PDS PlatesEthicon Inc.NHB2017-06-14
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10705031132528PDS PlatesEthicon Inc.NHB2017-06-14
10705031132535PDS PlatesEthicon Inc.NHB2017-06-14
20705031087931PDS PlatesETHICON INC.NHB2017-06-14