FDA.reportPublic FDA data

tarSys

Primary DI
00841668112229
Brand
tarSys
Company
KATENA PRODUCTS, INC.
Model
TS-121040
Catalog number
TS-121040
Device description
tarSys-Bio-engineered eyelid spacer 12 layer 1 x 4 cm
Published
2016-09-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXMProsthesis, Eyelid Spacer/Graft, Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXMProsthesis, Eyelid Spacer/Graft, BiologicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841668112229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668112229008416681122298416681122290841668112229

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid graftA device derived from animal tissues (porcine) that is prepared into sheets of various sizes and thicknesses appropriate for the grafting, reconstruction, and repair of the soft tissue of the eyelid. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Centimeter
Width1Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Ambient Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(973) 989-1600globe@katena.com

Regulatory Flags#

DUNS number
085668598
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668144299KatenaK3-9258K3-92582026-03-31
00841668144305KatenaK3-9259K3-92592026-03-31
00841668144312KatenaK3-9261K3-92612026-03-31
00841668144329KatenaK3-9262K3-92622026-03-31
00841668144336KatenaK3-9263K3-92632026-03-31
00841668144343KatenaK3-9264K3-92642026-03-31
00841668144350KatenaK3-9265K3-92652026-03-31
00841668144367KatenaK3-9266K3-92662026-03-31
00841668144374KatenaK3-9267K3-92672026-03-31
00841668144381KatenaK5-6220K5-62202026-03-31
00841668144398KatenaK3-9268K3-92682026-03-31
00841668144404KatenaK3-9269K3-92692026-03-31
00841668144428KatenaK3-9270K3-92702026-03-31
00841668144435KatenaK3-9274K3-92742026-03-31
00841668144442KatenaK3-9271K3-92712026-03-31
00841668144497BLINK60-127560-12752026-03-26
00841668144619BLINK60-163760-16372026-03-26
00841668144626BLINK60-163860-16382026-03-26
00841668144657BLINK60-500160-50012026-03-26
00841668144855BLINK60-510860-51082026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668112212tarSysKATENA PRODUCTS, INC.NXM2016-09-22
00850853006328tarSysInnovative Ophthalmic Products, IncNXM2016-01-06
00850853006335tarSysInnovative Ophthalmic Products, IncNXM2016-01-06
00850853006342keraSysInnovative Ophthalmic Products, IncNXM2016-01-06