FDA UDI
In Commercial Distribution
🇺🇸 United States
Hermann Medizintechnik GmbH
DI: 04059453022295
·
Model: H35-133-941
·
Hermann Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hermann Medizintechnik GmbH
- Primary DI
- 04059453022295
- Version / Model
- H35-133-941
- Company Name
- Hermann Medizintechnik GmbH
- Labeler DUNS
- 324868165
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-04
- Public Version
- 1
- Public Version Date
- 2021-05-12
- Public Version Status
- New
- Public Device Record Key
- 392efe41-c667-4ad8-b25c-7fab61eb424b
Device Description
DeBakey clamp, Ø10mm, WL 330mm, double action jaw, shaft insulated, metal handle/ ratchet, detachable
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
- No
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35080 | Rigid endoscopic tissue manipulation forceps, reusable | A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04059453022295 | GS1 |
Customer Contacts
- Phone
- +49746299670
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051610 | 000 |