← Back to catalogue
Crestone One Piece Implant ø3.50 L16mm
FDA UDIClass II (US FDA UDI)
by T.a.g Medical Products Agricultural Cooperative Association
Identity
- Trade Name
- Crestone One Piece Implant ø3.50 L16mm FDA UDI
- Generic Name
- Total haemoglobin (totHb) IVD, control FDA UDI
- Model / Reference
- B FDA UDI
Identifiers
- Catalog Number
- IC1-35016 FDA UDI
- Primary DI / UDI-DI
- 10810190010553 FDA UDI
- 510(k) Number
- K143326 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Total haemoglobin (totHb) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 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
No
FDA UDI
Category: Total haemoglobin (totHb) IVD, control
Crestone One Piece Implant ø3.50 L16mm by T.a.g Medical Products Agricultural Cooperative Association — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Total haemoglobin (totHb) IVD, control.
- hemochroma PLUS Optical System Check — IMMUNOSTICS, INC. · Class II
- DiaSpect Control Pack HBT4 — DiaSpect Medical GmbH · Class II
- DiaSpect Control HBT3 — EKF-diagnostic GmbH · Class II
- DiaSpect Control HBT2 — EKF-diagnostic GmbH · Class II
- Glycohemoglobin Bi-Level Controls — STANBIO LABORATORY, L.P. · Class II
- Eurotrol — Eurotrol B.V. · Class II
- Direct Glycohemoglobin (HbA1c) Control Set — STANBIO LABORATORY, L.P. · Class II
- Eurotrol — Eurotrol B.V. · Class II
Cleared under the same submission
K143326 also covers:
- 1/4" Abutment Fixture Short — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 15° Esthetic Abutment H1mm Ti — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 15° Esthetic Abutment H2mm Burn-Out — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 2.42 Retriever Key — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 25° Angulated Abutment H2mm Ti Wide — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 25° Esthetic Abutment H3mm Burn-Out — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 25° Temporary Abutment H1mm PEEK — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Anatomic Abutment H1mm L6mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Anatomic Abutment H1mm L8mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Anatomic Abutment H2mm L4mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Anatomic Abutment H3mm L6mm Wide — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Anatomic Healing Cap 4mm Wide — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
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
Sources (1)
- FDA UDI 9d62008b-5025-43db-a3ff-5959d87d93cd 34 fields · synced May 31, 2026