Identity
- Trade Name
- Puregraft Instrument Set FDA UDI
- Generic Name
- Instrument table FDA UDI
- Device Name
- Instrument Set EUDAMEDIs composed of the Puregraft Easel and Puregraft Slider. Both components are made of autoclavable stainless steel. The Easel holds the Puregraft Bag in place, and the Slider tool is used on the exterior of the Puregraft Bag to compress and facilitate the movement of liquids through the filter mesh and into the Drain Bag. FDA UDI
- Model / Reference
- 550/IS SST EUDAMEDFDA UDI
- Description
- Is composed of the Puregraft Easel and Puregraft Slider. Both components are made of autoclavable stainless steel. The Easel holds the Puregraft Bag in place, and the Slider tool is used on the exterior of the Puregraft Bag to compress and facilitate the movement of liquids through the filter mesh and into the Drain Bag. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850034511030 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850034511IS8B EUDAMED
- Direct Marketing DI
- 00850034511030 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L0318 INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE EUDAMED
- GMDN Term
- Instrument table 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
Yes
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
Instrument Set by Bimini Health Tech — 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 | 0850034511IS8B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bimini Health Tech
- EUDAMED SRN
- US-MF-000008649
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 574793ec-eb98-40f2-af58-7cdb708ac6c9 61 fields · synced Sep 17, 2026
- FDA UDI 639467a4-6b0f-41e1-8680-4be75a9e4435 33 fields · synced May 30, 2026