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Implanfield Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref HY1-0861Model Surgical Kits
by Hygitech
Identity
- Trade Name
- Implanfield Kit EUDAMEDHYGITECH FDA UDI
- Generic Name
- Denture repair kit, professional FDA UDI
- Device Name
- The IMPLANFIELD kit is designed for protecting the operating theatre. It is recommended for surgeries that are not implantology- or endodontology-specific. Indeed, these surgeries do not usually require an operating room meaning there are more surfaces to cover. The kit is composed of 25 items: 1 4 Polyethylene gloves 2 1 Plastic bag (50x80cm) 3 2 Adhesive films (5x80cm) 4 1 Tube support with adhesive 5 3 Protective sleeves for tubing (8x120cm) 6 1 Adhesive protective cover for control panel 7 2 Elastic cap handle covers 8 1 Protective PVC X-ray cover 9 2 Surgical drapes (75x75cm) 10 1 Instrument table cover (90x120cm) 11 1 Instrument table cover (bridge) (100x180cm) 12 1 Surgical drape with aperture and adhesive (75x90cm) 13 1 U-shaped surgical drape with adhesive (100x150cm) 14 3 Non-latex elastic bands 15 1 Wrapping paper The IMPLANFIELD kit is complementary to the IMPLANWEAR kit, which contains all clothing protection for the operation. The materials # Polypropylene non woven fabric # Laminated non-woven fabric # SMS Microfibre # Crepe paper FDA UDI
- Model / Reference
- Surgical Kits EUDAMEDHY1-0861 EUDAMEDHY-0861 FDA UDI
- Description
- The IMPLANFIELD kit is designed for protecting the operating theatre. It is recommended for surgeries that are not implantology- or endodontology-specific. Indeed, these surgeries do not usually require an operating room meaning there are more surfaces to cover. The kit is composed of 25 items: 1 4 Polyethylene gloves 2 1 Plastic bag (50x80cm) 3 2 Adhesive films (5x80cm) 4 1 Tube support with adhesive 5 3 Protective sleeves for tubing (8x120cm) 6 1 Adhesive protective cover for control panel 7 2 Elastic cap handle covers 8 1 Protective PVC X-ray cover 9 2 Surgical drapes (75x75cm) 10 1 Instrument table cover (90x120cm) 11 1 Instrument table cover (bridge) (100x180cm) 12 1 Surgical drape with aperture and adhesive (75x90cm) 13 1 U-shaped surgical drape with adhesive (100x150cm) 14 3 Non-latex elastic bands 15 1 Wrapping paper The IMPLANFIELD kit is complementary to the IMPLANWEAR kit, which contains all clothing protection for the operation. The materials # Polypropylene non woven fabric # Laminated non-woven fabric # SMS Microfibre # Crepe paper FDA UDI
Identifiers
- Catalog Number
- HY-0861 FDA UDI
- Primary DI / UDI-DI
- 03615140002462 EUDAMEDFDA UDI
- Basic UDI-DI
- 361514H2KITS100ISHC EUDAMED
- FDA Product Code
- KDD FDA UDI
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
- GMDN Term
- Denture repair kit, professional FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Implanfield Kit by Hygitech — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 361514H2KITS100ISHC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (2)
- EUDAMED e6c5bee2-1550-48cc-8669-f3a2a3bf022a 61 fields · synced Jun 19, 2026
- FDA UDI 2ebc2c06-de7f-439f-a607-4017cbd77459 34 fields · synced May 30, 2026