Identity
- Trade Name
- ATRAMAT FDA UDI
- Generic Name
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
- Device Name
- ATRAMAT POLYESTER SURGICAL SUTURE WHITE USP 5-0 EP 1, 45 CM DOUBLE NEEDLE EA-8 PREMIUM SPATULA 8 MM 1/4 CIRCLE POLIESTER BLANCO USP 5-0, 45 CM DOBLE AGUJA EA-8 ESPATULADA PREMIUM 8 MM 1/4 CIRCULO FDA UDI
- Model / Reference
- POLIESTER FDA UDI
- Description
- ATRAMAT POLYESTER SURGICAL SUTURE WHITE USP 5-0 EP 1, 45 CM DOUBLE NEEDLE EA-8 PREMIUM SPATULA 8 MM 1/4 CIRCLE POLIESTER BLANCO USP 5-0, 45 CM DOBLE AGUJA EA-8 ESPATULADA PREMIUM 8 MM 1/4 CIRCULO FDA UDI
Identifiers
- Catalog Number
- EA855/2-45B FDA UDI
- Primary DI / UDI-DI
- 07500142008337 FDA UDI
- 510(k) Number
- K905285 FDA UDI
- FDA Product Code
- GAS 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Millimeter FDA UDI
Category: Polyester suture, non-bioabsorbable, multifilament
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 Polyester suture, non-bioabsorbable, multifilament.
- WEGO-Polyester Nonabsorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- DemeBOND — DemeTECH Corp · Class II
- DemeBOND — DemeTECH Corp · Class II
- ETHIBOND EXCEL — Ethicon Inc. · Class II
- 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
K905285 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 225368e7-fba9-4248-9831-4ef70c6419f1 39 fields · synced Jun 8, 2026