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DemeSILK
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref SK265019F4PRef SK19620Ref SK260045F4PW
Identity
- Trade Name
- DemeSILK EUDAMEDFDA UDI
- Generic Name
- Silk suture FDA UDI
- Device Name
- DemeSILK EUDAMEDNonabsorbable Silk Surgical Suture FDA UDI
- Model / Reference
- SK265019F4P EUDAMEDFDA UDISK260045F4PW EUDAMEDFDA UDISK19620 EUDAMEDFDA UDISK266012F7P FDA UDI
- Description
- Nonabsorbable Silk Surgical Suture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10652927230090 EUDAMEDFDA UDI10652927357674 EUDAMEDFDA UDI10652927170839 EUDAMEDFDA UDI10652927248699 FDA UDI
- Basic UDI-DI
- B-10652927230090 EUDAMEDB-10652927170839 EUDAMEDB-10652927357674 EUDAMED
- 510(k) Number
- K023029 FDA UDI
- FDA Product Code
- GAP FDA UDI
- EMDN Code
- H010202020301 SILK WITH NEEDLE EUDAMEDH010202020302 SILK WITHOUT NEEDLE EUDAMED
- GMDN Term
- Silk suture FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5030 FDA UDI
- Market of Registration
- Italy EUDAMEDHungary EUDAMEDBulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Silk suture
DemeSILK by DemeTECH Corp — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Silk suture.
- Sofsilk — Covidien LP · Class II
- PERMA-HAND — Ethicon Inc. · Class II
- Sofsilk — Covidien LP · Class II
- DEKNATEL — TELEFLEX INCORPORATED · Class II
- Ds30 3-0 Bbs 18"/45cm — Surgical Specialties México, S. de R.L. de C.V. · Class II
- RTMED — Shandong Haidike Medical Products Co., Ltd. · Class II
- DEKNATEL — TELEFLEX INCORPORATED · Class II
- Sofsilk — Covidien LP · Class II
Cleared under the same submission
K023029 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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
- DemeTECH Corp
Sources (7)
- FDA UDI 66fe33b0-afca-41cb-b13c-6e35b10338a5 36 fields · synced Sep 17, 2026
- FDA UDI 3d371891-18f9-4ecb-bb13-1aef5539cdb3 36 fields · synced May 30, 2026
- FDA UDI f9be2900-d98f-4ddb-8536-98b5a30c0f6f 36 fields · synced May 30, 2026
- FDA UDI 8f19e1da-095e-4b4f-8884-0c21b5416f55 36 fields · synced May 30, 2026
- EUDAMED dc1bc602-821a-43d0-83ba-06653042a7d8 61 fields · synced Aug 1, 2026
- EUDAMED 166c5697-6ed7-4bce-98f8-1d5a5b61eed2 61 fields · synced Aug 1, 2026
- EUDAMED f333fdeb-f574-4327-a8d7-d5f1082c5355 61 fields · synced Sep 17, 2026