Identity
- Trade Name
- ATRAMAT FDA UDI
- Generic Name
- Poliglecaprone suture FDA UDI
- Device Name
- ATRAMAT PGC25 SURGICAL SUTURE UNDYED USP 6-0 EP 0.7, 45 CM NEEDLE P-PE-11 SUPRA-SHARP REVERSE CUTTING 11 MM 3/8 CIRCLE PGC25 INCOLORO USP 6-0, 45 CM AGUJA P-PE-11 REVERSO CORTANTE SUPRA-SHARP 11 MM 3/8 CIRCULO FDA UDI
- Model / Reference
- PGC25 FDA UDI
- Description
- ATRAMAT PGC25 SURGICAL SUTURE UNDYED USP 6-0 EP 0.7, 45 CM NEEDLE P-PE-11 SUPRA-SHARP REVERSE CUTTING 11 MM 3/8 CIRCLE PGC25 INCOLORO USP 6-0, 45 CM AGUJA P-PE-11 REVERSO CORTANTE SUPRA-SHARP 11 MM 3/8 CIRCULO FDA UDI
Identifiers
- Catalog Number
- P-PE1106-45B FDA UDI
- Primary DI / UDI-DI
- 07500142013942 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 — 11 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.
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
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- Henry Schein — HENRY SCHEIN, INC. · Class II
- Oasis — American Health Service Sales Corporation · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Oasis — American Health Service Sales Corporation · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
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 7e5cfa0a-d36c-4e03-b3b3-8177d14defb2 39 fields · synced Jun 8, 2026