FDA.reportPublic FDA data

Silverstein

Primary DI
20681490040802
Brand
Silverstein
Company
MEDTRONIC XOMED, INC.
Model
1428005
Device description
PACKING 1428005 6PK LONG STRIPS POLYEST
Published
2017-10-13
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOKMATERIAL, EXTERNAL AESTHETIC RESTORATION, NO ADHESIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOKMaterial, External Aesthetic Restoration, No AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20681490040802PackageGS16In Commercial Distribution
00681490040808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068149004080220681490040802
00681490040808006814900408086814900408080681490040808

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene craniofacial tissue reconstructive materialA sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.4Millimeter
Width50.8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
6
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169644656Otomag™ Attract™ Magnetic SpacerS0266-002016-04-15
00643169644663Otomag™ Attract™ Magnetic SpacerS0266-012016-04-15
00643169644670Otomag™ Attract™ Magnetic SpacerS0266-022016-04-15
00643169644687Otomag™ Attract™ Magnetic SpacerS0266-032016-04-15
00643169644694Otomag™ Attract™ Magnetic SpacerS0266-042016-04-15
00643169644700Otomag™ Attract™ Magnetic SpacerS0266-052016-04-15
00643169644717Otomag™ Attract™ Magnetic SpacerS0266-062016-04-15
00643169644731Otomag™ Attract™ Magnetic SpacerS0266-082016-04-15
00643169644748Otomag™ Attract™ Magnetic SpacerS0266-092016-04-15
00643169644755Otomag™ Attract™ Magnetic SpacerS0266-102016-04-15
00643169644762Otomag™ Attract™ Magnetic SpacerS0266-112016-04-15
00643169644779Otomag™ Attract™ Magnetic SpacerS0266-152016-04-15
00643169644786Otomag™ Attract™ Magnetic SpacerS0266-212016-04-15
00643169644793Otomag™ Attract™ Magnetic SpacerS0542-002016-04-15
00643169644809Otomag™ Attract™ Magnetic SpacerS0542-012016-04-15
00643169644816Otomag™ Attract™ Magnetic SpacerS0542-022016-04-15
00643169644823Otomag™ Attract™ Magnetic SpacerS0542-032016-04-15
00643169644830Otomag™ Attract™ Magnetic SpacerS0542-042016-04-15
00643169644847Otomag™ Attract™ Magnetic SpacerS0542-052016-04-15
00643169644854Otomag™ Attract™ Magnetic SpacerS0542-062016-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00645517110028TrulifeTrulife LimitedNOK2022-12-31
00645517110035TrulifeTrulife LimitedNOK2022-12-31
00645517110042TrulifeTrulife LimitedNOK2022-12-31
00645517110066TrulifeTrulife LimitedNOK2022-12-31
00645517110073TrulifeTrulife LimitedNOK2022-12-31
00645517110080TrulifeTrulife LimitedNOK2022-12-31
00645517110097TrulifeTrulife LimitedNOK2022-12-31
00645517110103TrulifeTrulife LimitedNOK2022-12-31
00645517110127TrulifeTrulife LimitedNOK2022-12-31
00645517110134TrulifeTrulife LimitedNOK2022-12-31
00645517110141TrulifeTrulife LimitedNOK2022-12-31
00645517110158TrulifeTrulife LimitedNOK2022-12-31
00645517110165TrulifeTrulife LimitedNOK2022-12-31
00645517110172TrulifeTrulife LimitedNOK2022-12-31
00645517110189TrulifeTrulife LimitedNOK2022-12-31
00645517110202TrulifeTrulife LimitedNOK2022-12-31
00645517110219TrulifeTrulife LimitedNOK2022-12-31
00645517110226TrulifeTrulife LimitedNOK2022-12-31
00645517110233TrulifeTrulife LimitedNOK2022-12-31
00645517110240TrulifeTrulife LimitedNOK2022-12-31
00645517110257TrulifeTrulife LimitedNOK2022-12-31
00645517110264TrulifeTrulife LimitedNOK2022-12-31
00645517110271TrulifeTrulife LimitedNOK2022-12-31
00645517110288TrulifeTrulife LimitedNOK2022-12-31
00645517110295TrulifeTrulife LimitedNOK2022-12-31
00645517110301TrulifeTrulife LimitedNOK2022-12-31
00645517110318TrulifeTrulife LimitedNOK2022-12-31
00645517110325TrulifeTrulife LimitedNOK2022-12-31
00645517112848TrulifeTrulife LimitedNOK2022-12-31
00645517112855TrulifeTrulife LimitedNOK2022-12-31