FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra®
DI: 10381780236306
·
Model: TRL31022S
·
Ascension Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra®
- Primary DI
- 10381780236306
- Version / Model
- TRL31022S
- Catalog Number
- TRL-310-22S
- Company Name
- Ascension Orthopedics, Inc.
- Labeler DUNS
- 942377524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-15
- Public Version
- 7
- Public Version Date
- 2023-01-25
- Public Version Status
- Update
- Public Device Record Key
- 6bb59f86-6b6c-4d32-8ecc-65a8724be621
- Distribution End Date
- 2026-12-31
Device Description
The Head Trial is used to verify proper implant placement and sizing.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| KWI | PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER | Orthopedic | 888.3170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58750 | Elbow humerus prosthesis trial | A copy of a final humerus prosthesis designed to be used for trial reductions during elbow arthroplasty to judge the correct size, length, condyle positioning, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M269TRL31022S1 | HIBCC | ||||
| Primary | 10381780236306 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032686 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | .880 in dia x .423 in H |