Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Scalpel handle, reusable FDA UDI
- Device Name
- 12" Bayonet Scalpel Handle, 6 3/4" WL, Knurled Handle FDA UDI
- Model / Reference
- SD4044-1021 FDA UDI
- Description
- 12" Bayonet Scalpel Handle, 6 3/4" WL, Knurled Handle FDA UDI
Identifiers
- Catalog Number
- SD4044-1021 FDA UDI
- Primary DI / UDI-DI
- B382SD404410210 FDA UDI
- FDA Product Code
- GDZ FDA UDI
- GMDN Term
- Scalpel handle, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
Yes
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
Category: Scalpel handle, reusable
Surgical Direct by Surgical Direct, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel handle, reusable.
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- Anterior Disc Prep — SeaSpine Orthopedics Corporation · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- HANDLE — KLS-Martin L.P. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Surgical Direct, Inc.
Sources (1)
- FDA UDI b51ff9f7-0124-45c4-99b7-27966e685298 35 fields · synced May 30, 2026