FDA UDI
In Commercial Distribution
🇺🇸 United States
Amalgatome SD 2-inch Cutting Head
DI: 00810006780031
·
Model: X100968
·
EXSURCO MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Amalgatome SD 2-inch Cutting Head
- Primary DI
- 00810006780031
- Version / Model
- X100968
- Catalog Number
- X100968
- Company Name
- EXSURCO MEDICAL, INC.
- Labeler DUNS
- 079319210
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-12
- Public Version
- 2
- Public Version Date
- 2021-06-22
- Public Version Status
- Update
- Public Device Record Key
- dd237289-f5b3-462c-b852-61d870af3548
Device Description
Blade Head 2" ASD; Excision ring blade head
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFD | Dermatome | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37473 | Dermatome handpiece, pneumatic | A pneumatically-powered, hand-held surgical instrument designed to cut from the body (harvest) thin donor slices of skin for skin grafting, or to excise small skin lesions, using a dedicated insertable blade (not included). This instrument will typically be driven by compressed gas [e.g., surgical-grade air, nitrogen (N2)] from a medical gas supply system. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810006780031 | GS1 |
Customer Contacts
- Phone
- 800-243-6049
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry