FDA.reportPublic FDA data

LATERA

Primary DI
00857037006006
Brand
LATERA
Company
STRYKER CORPORATION
Model
LATDD01
Device description
Delivery Device
Published
2016-07-21
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857037006990PackageGS16Not in Commercial Distribution
00857037006006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857037006990008570370069908570370069900857037006990
00857037006006008570370060068570370060060857037006006

GMDN Terms#

Term, Definition table
TermDefinition
Nasal cartilage support implant introducerA hand-held manual surgical instrument intended to introduce a nasal cartilage support 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.

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
07613327117189Neptune07030460000703-046-0002016-09-23
07613327117196Neptune07030460010703-046-0012016-09-23
07613327117202Neptune07030470000703-047-0002016-09-23
07613327117219Neptune07030470010703-047-0012016-09-23
07613327297799Neptune0703-165-0010703-165-0012016-09-23
07613327297805Neptune0703-120-0050703-120-0052016-09-23
07613327297812Neptune0703-007-0700703-007-0702016-09-23
07613327297829Neptune0703-165-0000703-165-0002016-09-23
07613327297836Neptune0703-125-0020703-125-0022016-09-23
07613327297843Neptune0703-070-0010703-070-0012016-09-23
07613327297850Neptune0703-216-0080703-216-0082016-09-23
07613327297867Neptune0703-320-0200703-320-0202016-09-23
07613327297874Neptune0703-216-0180703-216-0182016-09-23
07613327297881Neptune0703-213-0150703-213-0152016-09-23
07613327297898Neptune0703-320-0150703-320-0152016-09-23
07613327297904Neptune0703-310-0100703-310-0102016-09-23
07613327297911Neptune0703-070-0000703-070-0002016-09-23
07613327297928Neptune0703-125-0010703-125-0012016-09-23
07613327297935Neptune0703-620-0200703-620-0202016-09-23
07613327297942Neptune0703-213-0200703-213-0202016-09-23

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
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