Identity
- Trade Name
- NanoFUSE Bioactive Strip FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantation FDA UDI
- Model / Reference
- 100x25x7mm FDA UDI
- Description
- Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantation FDA UDI
Identifiers
- Catalog Number
- ASI209-20 FDA UDI
- Primary DI / UDI-DI
- 00858686006096 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial 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
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
NanoFUSE Bioactive Strip by Amend Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Amend Surgical, Inc.
Sources (1)
- FDA UDI 1e6f1507-1923-48fc-9e05-b082048cf5f5 37 fields · synced May 31, 2026