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Heyman-capsule, 6mm diameter x 17.5mm length, with mandrin for 320 mm needles
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Heyman-capsule, 6mm diameter x 17.5mm length, with mandrin for 320 mm needles FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11005110 FDA UDI
Identifiers
- Catalog Number
- GM11005110 FDA UDI
- Primary DI / UDI-DI
- 00816389023475 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
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6 Millimeter FDA UDI
Category: Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Heyman-capsule, 6mm diameter x 17.5mm length, with mandrin for 320 mm needles by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA…
Similar devices
Also classified as Cervical/intrauterine brachytherapy system applicator, remote-afterloading.
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- 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
K160045 also covers:
K983436 also covers:
- 4 cm intrauterine probe angled 20 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 5 cm intrauterine probe angled 20 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 5 cm intrauterine probe angled 40 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 6 cm intrauterine probe angled 40 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 7 cm intrauterine probe angled 20 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 7 cm intrauterine probe angled 40 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 8 cm intrauterine probe angled 40 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- Accessory Kit for Flexible Interstitial Implant Set, GammaMed — Varian Medical Systems Deutschland GmbH
- Base plate for 1.65mm steel needles — Varian Medical Systems Deutschland GmbH
- Basic Accessory Kit for Interstitial Applicators — Varian Medical Systems Deutschland GmbH
- Basic Accessory Kit for Intracavitary/GYN Applicators, GammaMed — Varian Medical Systems Deutschland GmbH
- Catheter Flap Set — Varian Medical Systems Deutschland GmbH
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
- Varian Medical Systems Deutschland GmbH
Sources (1)
- FDA UDI a0dc9832-2b3e-4d67-a262-fc8fd863eff1 35 fields · synced Jun 1, 2026