FDA UDI
In Commercial Distribution
🇺🇸 United States
ContourFlex™ Gluteal Implant Sizer Round
DI: M724CCB5SIZ6NS1
·
Model: CCB5-SIZ-6
·
IMPLANTECH ASSOCIATES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ContourFlex™ Gluteal Implant Sizer Round
- Primary DI
- M724CCB5SIZ6NS1
- Version / Model
- CCB5-SIZ-6
- Catalog Number
- CCB5-SIZ-6-NS
- Company Name
- IMPLANTECH ASSOCIATES, INC.
- Labeler DUNS
- 784664955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-20
- Public Version
- 1
- Public Version Date
- 2024-05-28
- Public Version Status
- New
- Public Device Record Key
- 48c4abc7-d533-4cbb-9a2c-eaf4b4822d5b
Device Description
ContourFlex™ Gluteal Implant Sizer Round
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
- 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 |
|---|---|---|---|---|
| MIB | Elastomer, Silicone Block | Ear, Nose, Throat | 874.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45230 | Silicone-block tissue reconstructive material | A non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M724CCB5SIZ6NS1 | HIBCC |
Customer Contacts
- Phone
- 1-800-733-0833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052504 | 000 |