FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra®
DI: 10381780257653
·
Model: CGT-60T
·
Ascension Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra®
- Primary DI
- 10381780257653
- Version / Model
- CGT-60T
- Company Name
- Ascension Orthopedics, Inc.
- Labeler DUNS
- 942377524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-25
- Public Version
- 6
- Public Version Date
- 2023-01-25
- Public Version Status
- Update
- Public Device Record Key
- e1ab80c0-ec77-492d-8731-8e8dbf355a51
- Distribution End Date
- 2026-12-31
Device Description
CGT Implant Size 60 The Classic Flexible Great Toe implant is a third generation prosthesis designed to supplement first metatarsophalangeal joint arthroplasty. Constructed from medical grade silicone elastomer, the Classic offers a patented axial offset hinge and other advanced design features while maintaining the surgical technique of the previous generation joint replacements
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 |
|---|---|---|---|---|
| KWH | PROSTHESIS, TOE, CONSTRAINED, POLYMER | Orthopedic | 888.3720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33700 | Total metatarsophalangeal joint prosthesis, one-piece | An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780257653 | GS1 | ||||
| Previous | 00846832006243 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023562 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 60 |