FDA.reportPublic FDA data

LATERA

Primary DI
00857037006921
Brand
LATERA
Company
ENTELLUS MEDICAL, INC.
Model
LATDD24
Device description
nasal implant 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
OTC
false
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
00857037006921PackageGS16In Commercial Distribution
00857037006105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857037006921008570370069218570370069210857037006921
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
017283879
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857326005536XeroGelXG-1022020-09-10
00857326005543XeroGelXG-1082020-09-10
10850002250210Shaver Blade 2.1mm Reusable Double Serrated StraightSSB-222-02020-09-25
10857326005731Shaver Blade 3mm Reusable Double Serrated Straight SSB-223-02020-09-25
10857326005748Shaver Blade 4mm Reusable Double Serrated Straight SSB-224-02020-09-25
10857326005755Shaver Blade 3mm Single Use Double Serrated StraightSSB-12300-1, SSB-12300-52020-09-25
10857326005762Shaver Blade 3mm Single Use Double Serrated 40° SSB-12340-1, SSB-12340-52020-09-25
10857326005779Shaver Blade 3mm Single Use Double Serrated 60°SSB-12360-1, SSB-12360-52020-09-25
10857326005786Shaver Blade 4mm Single Use Double Serrated Straight SSB-12400-1, SSB-12400-52020-09-25
10857326005793Shaver Blade 4mm Single Use Double Serrated 40° SSB-12440-1, SSB-12440-52020-09-25
10857326005809Shaver Blade 4mm Single Use Double Serrated 60° SSB-12460-1, SSB-12460-52020-09-25
10857326005830Shaver Blade 2.1mm Single Use Double Serrated StraightSSB-12200-1, SSB-12200-52020-09-25
00857326005550Entellus Medical Reinforced Anesthesia Needle RANRAN-027-22017-05-18
00857326005574Entellus Medical Reinforced Anesthesia Needle RANRAN-027-52017-05-18
00857037006990LATERALATDD012016-07-21
00857037006983LATERALATANI012016-07-21

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
00857037006082LATERASTRYKER CORPORATIONNHB2018-06-04
00857037006105LATERASTRYKER CORPORATIONNHB2017-09-19
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