Identity
- Trade Name
- Hermann Medizintechnik GmbH FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- DeBakey needle holder with TC, Ø5mm, WL 330mm, double action jaw, shaft insulated, axial handle/ ratchet,detachable FDA UDI
- Model / Reference
- H19-533-120HM FDA UDI
- Description
- DeBakey needle holder with TC, Ø5mm, WL 330mm, double action jaw, shaft insulated, axial handle/ ratchet,detachable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059453023278 FDA UDI
- 510(k) Number
- K051610 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Suturing needle holder, reusable
Hermann Medizintechnik GmbH by Hermann Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Suturing needle holder, reusable.
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Cleared under the same submission
K051610 also covers:
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hermann Medizintechnik GmbH
Sources (1)
- FDA UDI b69c3bcd-8b91-4c5c-856d-2e2b69dc7d5b 35 fields · synced Jun 8, 2026