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Atramat

FDA UDI

Class II (US FDA UDI)

by Internacional Farmacéutica S.A DE C.V

Identity

Trade Name
ATRAMAT FDA UDI
Generic Name
Silk suture FDA UDI
Device Name
ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1,5, 45 CM DOUBLE NEEDLE CE-12 REVERSE CUTTING 12 MM 3/8 CIRCLE SEDA NEGRA USP 4-0, 45 CM DOBLE AGUJA CE-12 REVERSO CORTANTE 12 MM 3/8 CIRCULO FDA UDI
Model / Reference
SEDA FDA UDI
Description
ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1,5, 45 CM DOUBLE NEEDLE CE-12 REVERSE CUTTING 12 MM 3/8 CIRCLE SEDA NEGRA USP 4-0, 45 CM DOBLE AGUJA CE-12 REVERSO CORTANTE 12 MM 3/8 CIRCULO FDA UDI

Identifiers

Catalog Number
CE1234/2 FDA UDI
Primary DI / UDI-DI
07500142003677 FDA UDI
510(k) Number
K905287 FDA UDI
FDA Product Code
GAP FDA UDI
GMDN Term
Silk suture FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5030 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 — 12 Millimeter FDA UDI

Category: Silk 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 Silk suture.

Cleared under the same submission

K905287 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Internacional Farmacéutica S.A DE C.V

Sources (1)

  • FDA UDI 07fae5f7-4c5a-446c-a411-e0f9efdfaa8e 39 fields · synced May 30, 2026