FDA UDI
In Commercial Distribution
🇺🇸 United States
tarSys
DI: 00850853006335
·
Model: TS-121040
·
Innovative Ophthalmic Products, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- tarSys
- Primary DI
- 00850853006335
- Version / Model
- TS-121040
- Catalog Number
- TS-121040
- Company Name
- Innovative Ophthalmic Products, Inc
- Labeler DUNS
- 793362583
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-01-06
- Public Version
- 3
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 31732355-7b2c-45f2-b15d-0373c86eaac4
Device Description
Bio-engineered eyelid spacer 12 layer 1 x 4 cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NXM | Prosthesis, Eyelid Spacer/Graft, Biologic | Ophthalmic | 886.3130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45357 | Eyelid xenograft | A 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850853006335 | GS1 |
Customer Contacts
- Phone
- 800-535-3545
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 1 | Centimeter | |
| Length | 4 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Ambient Temperature Storage