tarSys TS-81040
GUDID 00841668112212
tarSys-Bio-engineered eyelid spacer graft 8 layer 1 x 4 cm
KATENA PRODUCTS, INC.
Eyelid graft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft| Primary Device ID | 00841668112212 |
| NIH Device Record Key | 63797655-e48e-4e34-8f7a-3f85b166ac9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | tarSys |
| Version Model Number | TS-81040 |
| Catalog Number | TS-81040 |
| Company DUNS | 085668598 |
| Company Name | KATENA PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com |
Device Dimensions
| Length | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 1 Centimeter |
| Length | 4 Centimeter |
| Width | 1 Centimeter |
| Length | 4 Centimeter |
| Width | 1 Centimeter |
| Length | 4 Centimeter |
| Width | 1 Centimeter |
| Length | 4 Centimeter |
| Width | 1 Centimeter |
| Length | 4 Centimeter |
| Width | 1 Centimeter |
| Length | 4 Centimeter |
| Width | 1 Centimeter |
| Length | 4 Centimeter |
| Width | 1 Centimeter |
| Length | 4 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841668112212 [Primary] |
FDA Product Code
| NXM | Prosthesis, Eyelid Spacer/Graft, Biologic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-22 |
On-Brand Devices [tarSys]
| 00841668112229 | tarSys-Bio-engineered eyelid spacer 12 layer 1 x 4 cm |
| 00841668112212 | tarSys-Bio-engineered eyelid spacer graft 8 layer 1 x 4 cm |
Trademark Results [tarSys]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TARSYS 86032392 4497900 Live/Registered |
Innovative Ophthalmic Products, Inc. 2013-08-08 |
 TARSYS 77250107 not registered Dead/Abandoned |
INNOVATIVE OPHTHALMIC PRODUCTS, INC. 2007-08-08 |
 TARSYS 75241860 2138796 Dead/Cancelled |
Invacare Corporation 1997-02-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.