FDA UDI
In Commercial Distribution
🇺🇸 United States
GalaFLEX 3D
DI: 00810054980315
·
Model: 100042-06
·
Tepha, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GalaFLEX 3D
- Primary DI
- 00810054980315
- Version / Model
- 100042-06
- Catalog Number
- SH3D06
- Company Name
- Tepha, Inc.
- Labeler DUNS
- 039856765
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-29
- Public Version
- 7
- Public Version Date
- 2025-09-17
- Public Version Status
- Update
- Public Device Record Key
- 36cd3917-96c5-40ee-aac8-22a0122ef3b6
Device Description
GalaFLEX 3D Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 2)
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
- MR Safe
- 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 |
|---|---|---|---|---|
| OOD | Surgical Film | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44688 | Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable | An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polyglycolide] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810054980315 | GS1 |
Customer Contacts
- Phone
- 781-357-1750
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161092 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 7.5 | Centimeter | |
| Length | 21.0 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius