Identity
- Trade Name
- ATRAMAT FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Device Name
- ATRAMAT NYLON SURGICAL SUTURE BLACK USP 4-0 EP 1,5, 45 CM NEEDLE CE-16 REVERSE CUTTING 16 MM 3/8 CIRCLE NYLON NEGRO USP 4-0, 45 CM AGUJA CE-16 REVERSO CORTANTE 16 MM 3/8 CIRCULO FDA UDI
- Model / Reference
- NYLON FDA UDI
- Description
- ATRAMAT NYLON SURGICAL SUTURE BLACK USP 4-0 EP 1,5, 45 CM NEEDLE CE-16 REVERSE CUTTING 16 MM 3/8 CIRCLE NYLON NEGRO USP 4-0, 45 CM AGUJA CE-16 REVERSO CORTANTE 16 MM 3/8 CIRCULO FDA UDI
Identifiers
- Catalog Number
- CE1644-N FDA UDI
- Primary DI / UDI-DI
- 07500142003158 FDA UDI
- 510(k) Number
- K905286 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 16 Millimeter FDA UDI
Category: Nylon suture, non-bioabsorbable, monofilament
Atramat by Internacional Farmacéutica S.A DE C.V — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nylon suture, non-bioabsorbable, monofilament.
- DemeLON — DemeTECH Corp · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- DemeLON — DemeTECH Corp · Class II
- DemeLON — DemeTECH Corp · Class II
- SUPRAMID — S. Jackson, Inc. · Class II
- ETHILON — Ethicon Inc. · Class II
- UNIFY Nylon Surgical Sutures — APPLIED DENTAL, INC. · Class II
- DemeLON — DemeTECH Corp · Class II
Cleared under the same submission
K905286 also covers:
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
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
- Internacional Farmacéutica S.A DE C.V
Sources (1)
- FDA UDI 4ee737be-941c-48b4-b3fa-e77f302d09e6 39 fields · synced May 30, 2026