Identity
- Trade Name
- QuickLink™, TheraSeed® FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- QuickLink™ Cartridges with Model 200 TheraSeed® Palladium-103 FDA UDI
- Model / Reference
- 200QCS FDA UDI
- Description
- QuickLink™ Cartridges with Model 200 TheraSeed® Palladium-103 FDA UDI
Identifiers
- Catalog Number
- 200QCS FDA UDI
- Primary DI / UDI-DI
- 00801741078538 FDA UDI
- 510(k) Number
- K060636 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5730 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose brachytherapy system applicator, manualManual brachytherapy source, permanent implantBrachytherapy source spacer
QuickLink™, TheraSeed® by Bard Brachytherapy, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Brachytherapy source spacer.
- Theragenics — THERAGENICS CORP. · Class II
- Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, 3pk — Eckert & Ziegler BEBIG GmbH · Class I
- Theragenics — THERAGENICS CORP. · Class II
- Best Medical International — Best Medical International, Inc. · Class II
- Best Medical International — Best Medical International, Inc. · Class II
- Theragenics — THERAGENICS CORP. · Class II
- Spacer 1cm Synthetic 30 piece — Eckert & Ziegler BEBIG GmbH · Class II
- SPACER — RIVERPOINT MEDICAL LLC · Class II
Cleared under the same submission
K060636 also covers:
- QuickLink™, TheraSeed® — BARD BRACHYTHERAPY, INC
- QuickLink™, TheraSeed® — BARD BRACHYTHERAPY, INC
- TheraSeed® — BARD BRACHYTHERAPY, INC
- TheraSeed® — BARD BRACHYTHERAPY, INC
- TheraSeed® — BARD BRACHYTHERAPY, INC
- TheraSeed® — BARD BRACHYTHERAPY, INC
- TheraSeed® — BARD BRACHYTHERAPY, INC
- TheraSeed® — BARD BRACHYTHERAPY, INC
- TheraSeed®, SourceCap™ — BARD BRACHYTHERAPY, INC
- TheraSeed®, SourceCap™ — BARD BRACHYTHERAPY, INC
- TheraSeed®, SourceCap™ — BARD BRACHYTHERAPY, INC
- TheraSeed®, SourceCap™ — BARD BRACHYTHERAPY, INC
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
- Bard Brachytherapy, Inc
Sources (1)
- FDA UDI 509212da-68d5-4a4f-9fbe-997624c9ea7c 37 fields · synced May 30, 2026