Identity
- Trade Name
- Millennium FDA UDI
- Generic Name
- Rigid endoscopic biopsy forceps, reusable FDA UDI
- Device Name
- 5mm 45cm Biopsy Spoon Forceps, with tooth (Semm-Type), double action 10mm tip, rigid 1-piece with flush port FDA UDI
- Model / Reference
- 72-5215568A FDA UDI
- Description
- 5mm 45cm Biopsy Spoon Forceps, with tooth (Semm-Type), double action 10mm tip, rigid 1-piece with flush port FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776395063 FDA UDI
- 510(k) Number
- K181173 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Rigid endoscopic biopsy forceps, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid endoscopic biopsy forceps, reusable
Millennium by AVALIGN TECHNOLOGIES, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscopic biopsy forceps, reusable.
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- MaxMoreSpine — Hoogland Spine Products, GmbH · Class I
- JACKSON BIOPSY FORCEPS — SONTEC INSTRUMENTS, INC. · Class I
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH · Class II
- MaxMoreSpine — Hoogland Spine Products, GmbH · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- ELMED — ELMED INCORPORATED · Class II
- MaxMoreSpine — Hoogland Spine Products, GmbH · Class I
Cleared under the same submission
K181173 also covers:
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
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
- AVALIGN TECHNOLOGIES, Inc.
Sources (1)
- FDA UDI 4b7ba5fe-b964-4c1e-9f32-9ec21eabc845 35 fields · synced Jun 8, 2026