FDA UDI
In Commercial Distribution
🇺🇸 United States
Hermann Medizintechnik GmbH
DI: 04059453047359
·
Model: H118-22001
·
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
- 04059453047359
- Version / Model
- H118-22001
- Company Name
- Hermann Medizintechnik GmbH
- Labeler DUNS
- 324868165
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-12
- Public Version
- 1
- Public Version Date
- 2022-07-20
- Public Version Status
- New
- Public Device Record Key
- e11a201f-15c2-4320-b4f1-3b5b0c80a617
Device Description
Retractor (trach.), sharp, 1 prong
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDG | HOOK, SURGICAL, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64022 | Soft-tissue surgical hook, single-use | A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04059453047359 | GS1 |
Customer Contacts
- Phone
- +49746299670
- [email protected]