Identity
- Trade Name
- HERMESH FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
- Device Name
- Hermesh 4 cm 2,5x10 is a rectangular macroporous mesh with bi-directional elasticity, knitted with Polypropylene monofilament, indicated for both open and laparoscopic hernia repair FDA UDI
- Model / Reference
- H40210 FDA UDI
- Description
- Hermesh 4 cm 2,5x10 is a rectangular macroporous mesh with bi-directional elasticity, knitted with Polypropylene monofilament, indicated for both open and laparoscopic hernia repair FDA UDI
Identifiers
- Primary DI / UDI-DI
- 58032919890448 FDA UDI
- 510(k) Number
- K973955 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Hermesh by Herniamesh — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable.
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Cleared under the same submission
K973955 also covers:
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
- Herniamesh
Sources (1)
- FDA UDI 5f5344d4-a556-48eb-8fc2-389a0e666528 34 fields · synced May 31, 2026