FDA.reportPublic FDA data

LATERA

Primary DI
00857037006082
Brand
LATERA
Company
STRYKER CORPORATION
Model
LATANI24
Device description
Absorbable Nasal Implant 24mm
Published
2018-06-04
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
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
K161191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161191000Latera Absorbable Nasal ImplantSpirox, Inc.2016-06-23NHB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857037006082PrimaryGS10
00857037006129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857037006082008570370060828570370060820857037006082
00857037006129008570370061298570370061290857037006129

GMDN Terms#

Term, Definition table
TermDefinition
Nasal implant, synthetic polymer, bioabsorbableA sterile bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose by providing structural support to the cartilage to prevent nasal obstruction. It is a shaped device made of synthetic polymer materials [e.g., poly(L-lactide-co-D, L-lactide)] designed to gradually disintegrate following implantation. Dedicated devices intended to assist implantation through puncture of mucosal tissues may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length24Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius38 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21
07613327405927Precision IE 4K0502-445-0300502-445-0302019-01-21
07613327405934Precision IE 4K0502-444-0100502-444-0102019-01-21
07613327405941Precision IE 4K0502-445-0700502-445-0702019-01-21
07613327405958Precision IE 4K0502-444-0300502-444-0302019-01-21
07613327405965Precision IE 4K0502-445-0100502-445-0102019-01-21
07613327405972Precision IE 4K0502-444-0450502-444-0452019-01-21
07613327405989Precision IE 4K0502-444-1300502-444-1302019-01-21
07613327416299Precision IE 4K0502-194-0100502-194-0102019-01-21
07613327416305Precision IE 4K0502-194-0300502-194-0302019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011696308SeptAlignSPIRAIR, INC.NHB2024-10-16
00860011696315SeptAlignSPIRAIR, INC.NHB2024-10-16
00801741044083HEMADERMDavol Inc.NHB2023-10-09
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
00857037006105LATERASTRYKER CORPORATIONNHB2017-09-19
00857037006921LATERAENTELLUS MEDICAL, INC.NHB2017-09-19
10705031087965PDS PlatesEthicon Inc.NHB2017-06-15
10705031087989PDS PlatesEthicon Inc.NHB2017-06-15
20705031087962PDS PlatesEthicon Inc.NHB2017-06-15
20705031087986PDS PlatesEthicon Inc.NHB2017-06-15
10705031087934PDS PlatesEthicon Inc.NHB2017-06-14
10705031087941PDS PlatesEthicon Inc.NHB2017-06-14
10705031087958PDS PlatesEthicon Inc.NHB2017-06-14
10705031087972PDS PlatesEthicon Inc.NHB2017-06-14
10705031087996PDS PlatesEthicon Inc.NHB2017-06-14
10705031088009PDS PlatesEthicon Inc.NHB2017-06-14
10705031132511PDS PlatesEthicon Inc.NHB2017-06-14
10705031132528PDS PlatesEthicon Inc.NHB2017-06-14
10705031132535PDS PlatesEthicon Inc.NHB2017-06-14
20705031087931PDS PlatesETHICON INC.NHB2017-06-14
20705031087948PDS PlatesETHICON INC.NHB2017-06-14