FDA UDI
In Commercial Distribution
🇺🇸 United States
Scalpel, Handle, Fig.3S 12.5cm with scale for blades #9-17
DI: 04057034037744
·
Model: 16-0013
·
Geister Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Scalpel, Handle, Fig.3S 12.5cm with scale for blades #9-17
- Primary DI
- 04057034037744
- Version / Model
- 16-0013
- Catalog Number
- 16-0013
- Company Name
- Geister Medizintechnik GmbH
- Labeler DUNS
- 343548848
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-24
- Public Version
- 1
- Public Version Date
- 2023-08-01
- Public Version Status
- New
- Public Device Record Key
- bf4cc55b-7628-4248-9509-7dad2f08c993
Device Description
Scalpel, Handle, Fig.3S 12.5cm with scale for blades #9-17
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
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDZ | HANDLE, SCALPEL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12235 | Scalpel handle, reusable | A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04057034037744 | GS1 |
Customer Contacts
- Phone
- +497461966240
- [email protected]