Identity
- Trade Name
- nxt™ Bipolar Forceps FDA UDI
- Generic Name
- CD3 cell marker IVD, antibody FDA UDI
- Model / Reference
- wide flat handle, bayonet, non-stick silver FDA UDI
Identifiers
- Catalog Number
- BIP052USSU FDA UDI
- Primary DI / UDI-DI
- 04251388941881 FDA UDI
- 510(k) Number
- K191847 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- CD3 cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: CD3 cell marker IVD, antibody
nxt™ Bipolar Forceps by adeor Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CD3 cell marker IVD, antibody.
- CD3 (MRQ-39) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Mouse Monoclonal Anti-Human CD3(MX036) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- CD3 T-Cell — BIOCARE MEDICAL, LLC · Class I
- Human CD3 Pacific Blue™ Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Novocastra — Leica Biosystems Newcastle, Limited · Class I
- CD3 [BC33] — BIOCARE MEDICAL, LLC · Class I
- ANTI-CD3 (T CELL) — Biogenex Laboratories, Inc. · Class I
Cleared under the same submission
K191847 also covers:
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- adeor Medical AG
Sources (1)
- FDA UDI fdcef026-b75a-4974-a5d4-dd2b89c73f02 34 fields · synced May 30, 2026