Identity
- Trade Name
- ATRAMAT FDA UDI
- Generic Name
- Catgut suture, plain FDA UDI
- Device Name
- ATRAMAT PLAIN GUT SURGICAL SUTURE USP 4-0 EP 2, 75 CM NEEDLE PE-19 PREMIUM REVERSE CUTTING 19 MM 3/8 CIRCLE CATGUT SIMPLE USP 4-0, 75 CM AGUJA PE-19 REVERSO CORTANTE PREMIUM 19 MM 3/8 CIRCULO FDA UDI
- Model / Reference
- CATGUT SIMPLE FDA UDI
- Description
- ATRAMAT PLAIN GUT SURGICAL SUTURE USP 4-0 EP 2, 75 CM NEEDLE PE-19 PREMIUM REVERSE CUTTING 19 MM 3/8 CIRCLE CATGUT SIMPLE USP 4-0, 75 CM AGUJA PE-19 REVERSO CORTANTE PREMIUM 19 MM 3/8 CIRCULO FDA UDI
Identifiers
- Catalog Number
- PE1924-75 FDA UDI
- Primary DI / UDI-DI
- 07500142056468 FDA UDI
- 510(k) Number
- K911354 FDA UDI
- FDA Product Code
- GAI FDA UDI
- GMDN Term
- Catgut suture, plain FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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 — 19 Millimeter FDA UDI
Category: Catgut suture, plain
Atramat by Internacional Farmacéutica S.A DE C.V — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Catgut suture, plain.
- RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
- DemeGUT — DemeTECH Corp · Class II
- Plain Gut — Covidien LP · Class II
- Puragraft — Surgical Specialties México, S. de R.L. de C.V. · Class II
- DemeGUT — DemeTECH Corp · Class II
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- DemeGUT — DemeTECH Corp · Class II
- DemeGUT — DemeTECH Corp · Class II
Cleared under the same submission
K911354 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 I | Pending data |
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Manufacturer
- Manufacturer
- Internacional Farmacéutica S.A DE C.V
Sources (1)
- FDA UDI 10cb61e0-6a3b-4c56-9a3e-5704b8dabacb 39 fields · synced May 30, 2026