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Kobold® Tandem and 45 Deg Ring Applicator Set (E)
FDA UDIClass II (US FDA UDI)
by Kobold, Llc
Identity
- Trade Name
- Kobold® Tandem and 45 Deg Ring Applicator Set (E) FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- 707-003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815568020052 FDA UDI
- 510(k) Number
- K142330 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Angle — 45 degree FDA UDI
Category: Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Kobold® Tandem and 45 Deg Ring Applicator Set (E) by Kobold, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical/intrauterine brachytherapy system applicator, remote-afterloading.
- Ring CT/MR Applicator — Nucletron B.V. · Class II
- Cervix Rotterdam Applicator — Nucletron B.V. · Class II
- Utrecht Interstitial Fletcher CT/MR Applicator — Nucletron B.V. · Class II
- Utrecht Interstitial Fletcher CT/MR Applicator — Nucletron B.V. · Class II
- Best Medical International — Best Medical International, Inc. · Class I
- Vienna Ring CT/MR Applicator — Nucletron B.V. · Class II
- Fletcher Williamson Applicator — Nucletron B.V. · Class II
- Fletcher Williamson Applicator — Nucletron B.V. · Class II
Cleared under the same submission
K142330 also covers:
- Kobold® Tandem and 30 Deg Ring Applicator Set (E) — KOBOLD, LLC
- Kobold® Tandem and 30 Deg Ring Applicator Set (E) — KOBOLD, LLC
- Kobold® Tandem and 30/45/60 Deg Ring Applicator Set (E) — KOBOLD, LLC
- Kobold® Tandem and 30/45/60 Deg Ring Applicator Set (E) — KOBOLD, LLC
- Kobold® Tandem and 45 Deg Ring Applicator Set (E) — KOBOLD, LLC
- Kobold® Tandem and 60 Deg Ring Applicator Set (E) — KOBOLD, LLC
- Kobold® Tandem and 60 Deg Ring Applicator Set (E) — KOBOLD, LLC
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
- Kobold, Llc
Sources (1)
- FDA UDI 6c6ec0be-a02e-414f-bfcf-efdb6039d3a4 34 fields · synced May 30, 2026