FDA.reportPublic FDA data

Pureform

Primary DI
00850987007062
Brand
Pureform
Company
SURGICAL TECHNOLOGY LABORATORIES INC
Model
1ML04
Catalog number
1ML04
Device description
"""1ML04 PureForm - ePTFE Malar - Large"""
Published
2016-09-24
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

Product Codes#

Code, Name table
CodeName
LZKImplant, Malar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZKImplant, MalarGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091011000PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)Surgical Technology Laboratories, Inc ("Stl")2009-04-22FWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850987007062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850987007062008509870070628509870070620850987007062

GMDN Terms#

Term, Definition table
TermDefinition
Malar prosthesisAn implantable device designed to augment or maintain the soft-tissue anatomy of the malar area (cheek). The device is typically a solid elastomer (e.g., silicone) available in several shapes and sizes for subdermal implantation in the malar area for cosmetic or reconstructive purposes following traumatic or disease/congenital deformation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080380106
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854804007006SFAMSFAM603SFAM6032017-01-05
00854804007013SFAMSFAM803SFAM8032017-01-05
00854804007037SFAMSFAM503SFAM5032017-01-05
00854804007259SFAM PledgetPLG-6-RD2025-07-15
00854804007129SurgiPlast Nasal SplintSurgiPlast - Large - Skin Color - 1.6mm2024-09-30
00854804007136SurgiPlast Nasal SplintSurgiPlast - Large - Skin Color - 2.0mm2024-09-30
00854804007143SurgiPlast Nasal SplintSurgiPlast - Large - White Color - 1.6mm2024-09-30
00854804007150SurgiPlast Nasal SplintSurgiPlast - Large - White Color - 2.0mm2024-09-30
00854804007167SurgiPlast Nasal SplintSurgiPlast - Small - Skin Color - 1.6mm2024-09-30
00854804007174SurgiPlast Nasal SplintSurgiPlast - Small - Skin Color - 2.0mm2024-09-30
00854804007198SurgiPlast Nasal SplintSurgiPlast - Small - White Color - 1.6mm2024-09-30
00854804007204SurgiPlast Nasal SplintSurgiPlast - Small - White - 2.0mm2024-09-30
00854804007211SurgiPlast Nasal SplintSurgiPlast - Square - Skin Color - 1.6mm2024-09-30
00854804007228SurgiPlast Nasal SplintSurgiPlast - Square - Skin Color - 2.0mm2024-09-30
00854804007235SurgiPlast Nasal SplintSurgiPlast - Square - White Color - 1.6mm2024-09-30
00854804007242SurgiPlast Nasal SplintSurgiPlast - Square - White Color - 2.0mm2024-09-30
00851988007983Saf-T-Vac Smoke and Fluid EvacuatorST9000SST9000S2017-07-06
00854804007068PureForm6PN01*6PN01*2021-08-30
00854804007075PureForm4PN01*4PN01*2021-08-30
00854804007082PureForm5PN01*5PN01*2021-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M724BSMIISIZNS1Binder Submalar® II SizerIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724BSMSIZNS1Binder Submalar® SizerIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CBSMSIZNS1Conform Binder Submalar® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CCSMSIZNS1Conform Midfacial Implant SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CMASIZNS1Conform Mandibular Angle™ SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CSMSIZNS1Combined Submalar Shell™ SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CTMSSIZNS1Conform Terino Malar Shell® IMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724FTTSIZNS1Flowers Tear Trough® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724TMSSIZNS1Terino Malar Shell® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
00841036204181HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204198HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204204HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204211HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204228HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204235HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204242HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204259HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204273HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036204280HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-15
00841036203955HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-14
00841036203979HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-14
00841036203856HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-09
00841036203788HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-08
00841036203795HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-08
00841036203801HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-08
00841036203580HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-07
00841036203610HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-07
00841036203627HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-07
00841036203351HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-04
00841036203368HTR-PMIBIOMET MICROFIXATION, INCLZK2015-12-04