Identity
- Trade Name
- ATRAMAT FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
- Device Name
- ATRAMAT PDX SURGICAL SUTURE VIOLET USP 6-0 EP 0.7, 45 CM NEEDLE HPE-11 ATRAGLIDE CUTTING 11 MM 3/8 CIRCLE POLIDIOXANONA VIOLETA USP 6-0, 45 CM AGUJA HPE-11 CORTANTE ATRAGLIDE 11 MM 3/8 CIRCULO FDA UDI
- Model / Reference
- PDX FDA UDI
- Description
- ATRAMAT PDX SURGICAL SUTURE VIOLET USP 6-0 EP 0.7, 45 CM NEEDLE HPE-11 ATRAGLIDE CUTTING 11 MM 3/8 CIRCLE POLIDIOXANONA VIOLETA USP 6-0, 45 CM AGUJA HPE-11 CORTANTE ATRAGLIDE 11 MM 3/8 CIRCULO FDA UDI
Identifiers
- Catalog Number
- HPE1176-45 FDA UDI
- Primary DI / UDI-DI
- 07500142080470 FDA UDI
- 510(k) Number
- K041048 FDA UDI
- FDA Product Code
- NEW FDA UDI
- GMDN Term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4840 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 — 11 Millimeter FDA UDI
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
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, bioabsorbable, monofilament, non-antimicrobial.
- Monoswift — RIVERPOINT MEDICAL LLC · Class II
- DemeDIOX — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- WEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- Maxon — Covidien LP · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
Cleared under the same submission
K041048 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 b155721e-7faf-4316-a051-ba547ec3435e 39 fields · synced May 30, 2026