FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Titan™ Modular Shoulder System
DI: 10381780282518
·
Model: TSSRETRACIMP
·
Ascension Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Titan™ Modular Shoulder System
- Primary DI
- 10381780282518
- Version / Model
- TSSRETRACIMP
- Catalog Number
- TSSRETRACIMP
- Company Name
- Ascension Orthopedics, Inc.
- Labeler DUNS
- 942377524
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-13
- Public Version
- 3
- Public Version Date
- 2023-05-02
- Public Version Status
- Update
- Public Device Record Key
- 25ec4142-88b8-46f4-a6ac-85d67d598546
- Distribution End Date
- 2023-03-31
Device Description
Retractor Set Modular Shoulder System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAD | RETRACTOR | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45182 | Self-retaining surgical retractor, reusable | A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M248TSSRETRACIMP1 | HIBCC | ||||
| Primary | 10381780282518 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]