FDA UDI
In Commercial Distribution
🇺🇸 United States
STOMA®
DI: ESAM6071001
·
Model: 6071.00
·
Storz am Mark GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- STOMA®
- Primary DI
- ESAM6071001
- Version / Model
- 6071.00
- Catalog Number
- 6071.00
- Company Name
- Storz am Mark GmbH
- Labeler DUNS
- 318268125
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-27
- Public Version
- 1
- Public Version Date
- 2020-09-04
- Public Version Status
- New
- Public Device Record Key
- bf55f598-251b-4be0-8222-eed60556a340
Device Description
Wire bending pliers, How, curved,14cm
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
- 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 |
|---|---|---|---|---|
| JEX | PLIER, ORTHODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32886 | Wire holding/twisting forceps | A surgical instrument with specially designed sturdy blades used to grip, tighten and/or twist wires that are being applied to the patient during a surgical intervention. It typically has a scissors-like design with ring handles, is made of high-grade stainless steel and may be self-retaining. It is available in various sizes and the working end can have a variety of jaw designs, e.g., typically short and broad with carbide inserts, but some may be long with side protruding posts around which the loose end of the wire are secured to provide greater grip. The blades/handles are typically strong in profile. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | ESAM6071000 | HIBCC | ||||
| Primary | ESAM6071001 | HIBCC |
Customer Contacts
- Phone
- +49746592600
- [email protected]