FDA.reportPublic FDA data

LATERA

Primary DI
00857037006105
Brand
LATERA
Company
STRYKER CORPORATION
Model
LATDD24
Device description
24mm Delivery Device
Published
2017-09-19
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
00857037006105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857037006105008570370061058570370061050857037006105

GMDN Terms#

Term, Definition table
TermDefinition
Nasal implant introducerA sterile, hand-held manual surgical instrument intended to be used to introduce a nasal implant into the nasal soft tissues (e.g., between the nasal mucosa and the cartilage). It is in the form of a syringe-like tool with a plunger and a stainless steel cannula designed to be inserted through the nasal mucosa tissue, via the nasal cavity, to deploy the implant. This is a single-use device.

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
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15
07613327504019NA5407-150-0005407-150-0002021-07-08
07613327504057NA5407-350-0005407-350-0002021-07-08
07613154495771NA62930000006293-000-0002015-09-24
07613154495801NA62970000006297-000-0002015-09-24
07613154495818NA62980000006298-000-0002015-09-24
07613154501410Electric System 6 Stryker Precision62990000006299-000-0002018-09-23
00850002250411ClariFixCFX-2002CFX-20022020-09-01
04546540517593ESSx52906012005290-601-2002016-09-24
07613327665109Sonopet iQ+55002600005500-260-0002026-10-14
07613327685114Sonopet iQ57000500005700-050-0002026-10-14
07613327665031Sonopet iQ+550026B0105500-26B-0102026-10-12
07613327665048Sonopet iQ+550026B0205500-26B-0202026-10-12
07613327665055Sonopet iQ+550026B1145500-26B-1142026-10-12
07613327665062Sonopet iQ+550026B3125500-26B-3122026-10-12
07613327687149Sonopet iQ+550026B3285500-26B-3282026-10-12
07613327662030ALPHAVENT3911-856-5473911-856-5472025-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011696346SeptAlignSPIRAIR, INC.NHB2026-08-03
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
00857037006082LATERASTRYKER CORPORATIONNHB2018-06-04
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