Identity
- Trade Name
- ProSup FDA UDI
- Generic Name
- Dental handpiece maintenance unit FDA UDI
- Device Name
- Pelvic Floor Repair Mesh,Polyester,15 cm x 3.5 cm;18 cm x 6 cm FDA UDI
- Model / Reference
- TECGK06 FDA UDI
- Description
- Pelvic Floor Repair Mesh,Polyester,15 cm x 3.5 cm;18 cm x 6 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521177604 FDA UDI
- 510(k) Number
- K982532 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Dental handpiece maintenance unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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: Dental handpiece maintenance unit
ProSup by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental handpiece maintenance unit.
- F-Type Adaptor — NAKANISHI INC. · Class I
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- Maintenance Oil — NAKANISHI INC. · Class I
- CareMaster — Beyes Dental Canada Inc · Class I
- Assistina 301+ — W & H Dentalwerk Bürmoos GmbH · Class I
- F-Type Adaptor — NAKANISHI INC. · Class I
- F-Type Adaptor 4H — NAKANISHI INC. · Class I
- BeyesLube — Beyes Dental Canada Inc · Class I
Cleared under the same submission
K982532 also covers:
- ProSup — Covidien LP
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
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
- Covidien LP
Sources (1)
- FDA UDI e187fba8-254b-48b4-b976-19ba3945a50c 35 fields · synced May 30, 2026