Identity
- Trade Name
- Ballast FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
- Device Name
- Ballast®, 150x11mm, 2-pack FDA UDI
- Model / Reference
- 02-1100-000 FDA UDI
- Description
- Ballast®, 150x11mm, 2-pack FDA UDI
Identifiers
- Catalog Number
- 02-1100-000 FDA UDI
- Primary DI / UDI-DI
- 10889981232139 FDA UDI
- 510(k) Number
- K200290 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Ballast by Isotis Orthobiologics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable.
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- Phasix — Davol Inc. · Class II
- GalaFLEX LITE — Tepha, Inc. · Class II
- NEOVEIL — GUNZE LIMITED · Class II
Cleared under the same submission
K200290 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Isotis Orthobiologics, Inc
Sources (1)
- FDA UDI ba404fdd-64f4-4289-86e7-ba0c0e3400fa 37 fields · synced Jun 8, 2026