Identity
- Trade Name
- Axiom® FDA UDI
- Generic Name
- Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
- Device Name
- Penrose Tubing, Silicone, With Holes FDA UDI
- Model / Reference
- 101225H FDA UDI
- Description
- Penrose Tubing, Silicone, With Holes FDA UDI
Identifiers
- Primary DI / UDI-DI
- M665101225H0 FDA UDI
- 510(k) Number
- K781749 FDA UDI
- FDA Product Code
- KDH FDA UDI
- GMDN Term
- Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.25 Inch FDA UDILength — 12 Inch FDA UDI
Category: Surgical capillary wound drain, luminal, synthetic polymer
Axiom® by Axiom Medical, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical capillary wound drain, luminal, synthetic polymer.
- TAUT — TELEFLEX INCORPORATED · Class II
- Silicone Tubing, Translucent — Bentec Medical OpCo, LLC. · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Silicone Tubing, Penrose Drain — Bentec Medical OpCo, LLC. · Class I
- Malecot — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class I
- Silicone Tubing, Radiopaque — Bentec Medical OpCo, LLC. · Class I
- Silicone Tubing, Penrose Drain — Bentec Medical OpCo, LLC. · Class I
Cleared under the same submission
K781749 also covers:
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® — AXIOM MEDICAL, INCORPORATED
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
- Axiom Medical, Incorporated
Sources (1)
- FDA UDI 9e914e1f-7448-4fc4-889d-9c96b7410094 36 fields · synced Jun 6, 2026