Stitch Cerclage - Suture Tapes

FDA UDI

Class II (US FDA UDI)

by Gm Dos Reis Industria E Comercio Ltda

Identity

Trade Name: Stitch Cerclage - Suture Tapes FDA UDI
Generic Name: Surgical support tape, non-bioabsorbable FDA UDI
Device Name: STERNAL STITCH CERCLAGE - Suture Tape UHMWPE white 2,5mm with curved needle 1/2 48mm blunt tip FDA UDI
Model / Reference: 333-ECBR-25-1248RB FDA UDI
Description: STERNAL STITCH CERCLAGE - Suture Tape UHMWPE white 2,5mm with curved needle 1/2 48mm blunt tip FDA UDI

Identifiers

Primary DI / UDI-DI: 07899258697024 FDA UDI
FDA Product Code: JDQ FDA UDI
GMDN Term: Surgical support tape, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3010 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Surgical support tape, non-bioabsorbable

Stitch Cerclage - Suture Tapes by Gm Dos Reis Industria E Comercio Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Gm Dos Reis Industria E Comercio Ltda

Sources (1)

FDA UDI 52b08387-6678-4e48-869a-7e51594a0cc3 33 fields · synced Jun 8, 2026