Identity
- Trade Name
- ATRAMAT FDA UDI
- Generic Name
- Catgut suture, chromic FDA UDI
- Device Name
- ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 4-0 EP 2, 30 CM DOUBLE NEEDLE E-EA-8 SUPRAGLYDE SPATULA 8 MM 1/4 CIRCLE CATGUT CROMICO USP 4-0, 30 CM DOBLE AGUJA E-EA-8 ESPATULADA SUPRAGLYDE 8 MM 1/4 CIRCULO FDA UDI
- Model / Reference
- CATGUT CROMICO FDA UDI
- Description
- ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 4-0 EP 2, 30 CM DOUBLE NEEDLE E-EA-8 SUPRAGLYDE SPATULA 8 MM 1/4 CIRCLE CATGUT CROMICO USP 4-0, 30 CM DOBLE AGUJA E-EA-8 ESPATULADA SUPRAGLYDE 8 MM 1/4 CIRCULO FDA UDI
Identifiers
- Catalog Number
- E-EA814/2-30 FDA UDI
- Primary DI / UDI-DI
- 07500142080340 FDA UDI
- 510(k) Number
- K911354 FDA UDI
- FDA Product Code
- GAI FDA UDI
- GMDN Term
- Catgut suture, chromic 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 — 8 Millimeter FDA UDI
Category: Catgut suture, chromic
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, chromic.
- DemeGUT — DemeTECH Corp · Class II
- DemeGUT — DemeTECH Corp · Class II
- ETHICON — Ethicon Inc. · Class II
- DemeGUT — DemeTECH Corp · Class II
- ETHICON — Ethicon Inc. · Class II
- ACE Surgical Ch Gut 3-0 30" Hr26 — Surgical Specialties México, S. de R.L. de C.V. · 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 eca4c0b1-39f1-49ee-96a7-1c8165eccb47 39 fields · synced May 31, 2026