FDA UDI
In Commercial Distribution
🇺🇸 United States
ZOLL-DENTAL
DI: 00840105214847
·
Model: Z-1011
·
Zoll-Dental
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZOLL-DENTAL
- Primary DI
- 00840105214847
- Version / Model
- Z-1011
- Company Name
- Zoll-Dental
- Labeler DUNS
- 005449822
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-10
- Public Version
- 3
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- ef900d01-90f9-4342-98bd-b1a8e330097d
Device Description
#17 English Forceps
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| HTD | FORCEPS | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35552 | Tooth extraction forceps | A hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840105214847 | GS1 |
Customer Contacts
- Phone
- +1(847)647-1819 ext. 505
- [email protected]