Identity
- Trade Name
- Dymaxeon FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- T30 Cap Adjuster FDA UDI
- Model / Reference
- 06.0 FDA UDI
- Description
- T30 Cap Adjuster FDA UDI
Identifiers
- Catalog Number
- 77.2069 FDA UDI
- Primary DI / UDI-DI
- 00815500023622 FDA UDI
- 510(k) Number
- K121786 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Surgical screwdriver, reusable
Dymaxeon by Back 2 Basic Direct, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
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- USS — Synthes · Class I
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Cleared under the same submission
K121786 also covers:
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
- Dymaxeon — BACK 2 BASIC DIRECT, LLC
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
- Back 2 Basic Direct, Llc
Sources (1)
- FDA UDI 9633308e-ae68-4900-99cd-f0e37ca30f5d 36 fields · synced May 31, 2026