Identity
- Trade Name
- TESSYS® Metal Hammer Cap EUDAMEDTESSYS® FDA UDI
- Generic Name
- Surgical mallet head FDA UDI
- Device Name
- CESSYS® Metal Hammer EUDAMEDTESSYS® Metal Hammer Cap FDA UDI
- Model / Reference
- TMHC2208B EUDAMEDFDA UDI
- Description
- TESSYS® Metal Hammer Cap FDA UDI
Identifiers
- Catalog Number
- TMHC2208B FDA UDI
- Primary DI / UDI-DI
- 04250337101642 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371H+MMCM EUDAMED
- Direct Marketing DI
- 04250337101642 EUDAMED
- FDA Product Code
- FZY FDA UDI
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Surgical mallet head FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical mallet head
Tessys® by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical mallet head.
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- Pomee — POMEE CORPORATION · Class I
- Alliant Biotech — Medisurge · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 49ee06c0-731d-4035-8457-135a6446788e 36 fields · synced Jun 18, 2026
- EUDAMED e5a3c198-60f2-4fd1-b957-a3846546c451 61 fields · synced Jun 18, 2026