Identity
- Trade Name
- Miracu BI FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
- Model / Reference
- Miracu BI 21Gx60mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18809407786161 FDA UDI
- 510(k) Number
- K172602 FDA UDI
- FDA Product Code
- NEW FDA UDI
- GMDN Term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Miracu BI by Feeltech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
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- Maxon — Covidien LP · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
Cleared under the same submission
K172602 also covers:
- AMI Custom Crafted FCL | 19G x 40mm — Feeltech Co., Ltd.
- AMI Custom Crafted FCL | 20G x 90mm — Feeltech Co., Ltd.
- AMI Custom Crafted FCL | 21G x 90mm — Feeltech Co., Ltd.
- AMI Custom Crafted FCN | 21G x 90mm — Feeltech Co., Ltd.
- AMI Custom Crafted Flex Trellis | 21G x 30mm — Feeltech Co., Ltd.
- AMI Custom Crafted | Spec Basic | 18G x 100mm — Feeltech Co., Ltd.
- AMI Customer Crafted Barb Bi | 21G x 60mm — Feeltech Co., Ltd.
- AMI Standard Barb FC | 21G x 60mm — Feeltech Co., Ltd.
- ELASTY FCN FORTE2 18Gx100mm — Feeltech Co., Ltd.
- ELASTY Line — Feeltech Co., Ltd.
- ELASTY MESHFILL — Feeltech Co., Ltd.
- ELASTY MESHFILL — Feeltech Co., Ltd.
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
- Feeltech Co., Ltd.
Sources (1)
- FDA UDI 40c83588-97d3-4979-980a-9a13ceab32af 33 fields · synced May 30, 2026