Identity
- Trade Name
- AngelMed Guardian Torque Wrench FDA UDI
- Generic Name
- Surgical torque wrench, single-use FDA UDI
- Device Name
- Hex Torque Wrench (Separate, in Sterile Pack) FDA UDI
- Model / Reference
- 2100-001 FDA UDI
- Description
- Hex Torque Wrench (Separate, in Sterile Pack) FDA UDI
Identifiers
- Catalog Number
- 2100-001 FDA UDI
- Primary DI / UDI-DI
- 00850012625018 FDA UDI
- PMA Number
- P150009 FDA UDI
- FDA Product Code
- QBI FDA UDI
- GMDN Term
- Surgical torque wrench, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: Surgical torque wrench, single-use
AngelMed Guardian Torque Wrench by Avertix Medical Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P150009 also covers:
- AngelMed Guardian EXD Carrying Case — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Lanyard — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Model EXD-001 — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Model EXD-001 — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Model EXD-001 Battery — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Model EXD-001 Battery, 10 Pack — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Model EXD-001 Battery, 30 Pack — AVERTIX MEDICAL INC.
- AngelMed Guardian IMD Model AMSG3-E — AVERTIX MEDICAL INC.
- AngelMed Guardian Programmer Application User's Manual CD — AVERTIX MEDICAL INC.
- AngelMed Guardian Programmer External Power Accessories — AVERTIX MEDICAL INC.
- AngelMed Guardian Programmer Model PROG-003 — AVERTIX MEDICAL INC.
- AngelMed Guardian Programmer PROG-003 Carrying Case — AVERTIX MEDICAL INC.
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avertix Medical Inc.
Sources (1)
- FDA UDI 85de1883-d02c-4d23-9230-ac29d596219c 35 fields · synced May 30, 2026