FDA UDI
In Commercial Distribution
🇺🇸 United States
Main-Mallet-Spinal Simplicity
DI: B908350011000
·
Model: 316-35-911
·
Mainstream Medical Devices, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Main-Mallet-Spinal Simplicity
- Primary DI
- B908350011000
- Version / Model
- 316-35-911
- Catalog Number
- 35-0011-000
- Company Name
- Mainstream Medical Devices, LLC
- Labeler DUNS
- 071513432
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-04
- Public Version
- 1
- Public Version Date
- 2025-04-14
- Public Version Status
- New
- Public Device Record Key
- aadb433c-8229-41e0-923e-8d7e7350ac45
Device Description
Single-Use, Surgical Mallet, Slotted, 8" Small Contoured Handle, 16oz Head Weight, Spinal Simplicity, Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HXL | Mallet | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32312 | Surgical mallet | A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B908350011000 | HIBCC |
Customer Contacts
- Phone
- 512-289-3437
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1 | Pound | |
| Length | 8 | Inch |