Identity
- Trade Name
- DemeLON FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Device Name
- Nylon Monofilament, Sterile, Nonabsorbable Surgical Suture FDA UDI
- Model / Reference
- NL176013F13M FDA UDI
- Description
- Nylon Monofilament, Sterile, Nonabsorbable Surgical Suture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10652927694953 FDA UDI
- 510(k) Number
- K023028 FDA UDI
- FDA Product Code
- GAR FDA UDI
- GMDN Term
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5020 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
No
FDA UDI
Category: Nylon suture, non-bioabsorbable, monofilament
DemeLON by DemeTECH Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nylon suture, non-bioabsorbable, monofilament.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- SUPRAMID — S. Jackson, Inc. · Class II
- ETHILON — Ethicon Inc. · Class II
- UNIFY Nylon Surgical Sutures — APPLIED DENTAL, INC. · Class II
- FSSB Nylon Suture — Fssb Chirurgische Nadeln GmbH · Class II
- ETHILON — Ethicon Inc. · Class II
- WEGO-Nylon Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- 2hgl5 11-0 Bk Mono Nyl 6"/15cm — Surgical Specialties México, S. de R.L. de C.V. · Class II
Cleared under the same submission
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
- DemeTECH Corp
Sources (1)
- FDA UDI 79583424-adde-401e-8ab7-def1fc29490d 36 fields · synced May 30, 2026