Identity
- Trade Name
- RTMED FDA UDI
- Generic Name
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
- Model / Reference
- 1# Round Bodied 1/2 40mm 75cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971642806821 FDA UDI
- 510(k) Number
- K231183 FDA UDI
- FDA Product Code
- GAT FDA UDI
- GMDN Term
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 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
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
Yes
FDA UDI
MR Safe FDA UDI
Category: Polyester suture, non-bioabsorbable, multifilament
Rtmed by Shandong Haidike Medical Products Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyester suture, non-bioabsorbable, multifilament.
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- DemeBOND — DemeTECH Corp · Class II
- DEKNATEL — TELEFLEX INCORPORATED · Class II
- Ti-Cron — Covidien LP · Class II
- DEKNATEL — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K231183 also covers:
- RTMED — Shandong Haidike Medical Products Co., Ltd.
- RTMED — Shandong Haidike Medical Products Co., Ltd.
- RTMED — Shandong Haidike Medical Products Co., Ltd.
- RTMED — Shandong Haidike Medical Products Co., Ltd.
- RTMED — Shandong Haidike Medical Products Co., Ltd.
- RTMED — Shandong Haidike Medical Products Co., Ltd.
- RTMED — Shandong Haidike Medical Products Co., Ltd.
- RTMED — Shandong Haidike Medical Products Co., Ltd.
- RTMED — Shandong Haidike Medical Products Co., Ltd.
- RTMED — Shandong Haidike Medical Products Co., Ltd.
- RTMED — Shandong Haidike Medical Products Co., Ltd.
- RTMED — Shandong Haidike Medical Products 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shandong Haidike Medical Products Co., Ltd.
Sources (1)
- FDA UDI c7886e90-e7be-469a-be48-ada036d549aa 33 fields · synced May 30, 2026