Identity
- Trade Name
- ATRAMAT FDA UDI
- Generic Name
- Poliglecaprone suture FDA UDI
- Device Name
- ATRAMAT PGLA90 SURGICAL SUTURE VIOLET USP 6-0 EP 0.7, 45 CM DOUBLE NEEDLE E-EA-8 SUPRAGLYDE SPATULA 8 MM 1/4 CIRCLE PGLA90 VIOLETA USP 6-0, 45 CM DOBLE AGUJA E-EA-8 ESPATULADA SUPRAGLYDE 8 MM 1/4 CIRCULO FDA UDI
- Model / Reference
- PGLA90 FDA UDI
- Description
- ATRAMAT PGLA90 SURGICAL SUTURE VIOLET USP 6-0 EP 0.7, 45 CM DOUBLE NEEDLE E-EA-8 SUPRAGLYDE SPATULA 8 MM 1/4 CIRCLE PGLA90 VIOLETA USP 6-0, 45 CM DOBLE AGUJA E-EA-8 ESPATULADA SUPRAGLYDE 8 MM 1/4 CIRCULO FDA UDI
Identifiers
- Catalog Number
- E-EA8306/2 FDA UDI
- Primary DI / UDI-DI
- 07500142063763 FDA UDI
- 510(k) Number
- K072863 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Poliglecaprone suture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4493 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Poliglecaprone suture
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 Poliglecaprone suture.
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- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
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- Oasis — American Health Service Sales Corporation · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Oasis — American Health Service Sales Corporation · Class II
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Cleared under the same submission
K072863 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 03f06064-f7be-4241-8a63-371730ffd346 38 fields · synced May 31, 2026