Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004845555

FEI Number

3004845555

Entity Name

UNILENE, SAC

City/State/Country

Lima Lima (Region), PE

Establishment Address

Napo No. 450, Lima Lima (Region) 15082, PE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Unilene, SAC (Owner Number: 10035000)

Owner / Operator Contact Address

Napo No. 450, Lima, PE-LIM 15082, PE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ventury Low Concentration Oxygen Mask Sutumed, Gamed, U-Mask, Cirugia Peruana Rebreathing - Non-rebreathing Oxygen Mask Sutumed, Gamed, U-Mask, Cirugia Peruana Polyglecaprone - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus Polyglicolic Acid - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus Polyglactin - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus Polydioxanone - Synthetic Absorbable Suture Sutumed, Vital Sutures, Suturex, Cirugia Peruana Plus Protection Shield - Protection Mask Sutumed, Gamed, U-Mask, Cirugia Peruana

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2020-04-27
BYW	Device, Rebreathing	Anesthesiology	Class 1	868.5675	2020-04-27
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2011-01-25
GAN	Suture, Absorbable, Synthetic	General, Plastic Surgery	Class 2	878.4830	2011-01-25
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2011-01-25
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-05-06

Official Correspondent

Martha Lujan

US Agent Details

Louis Sun Email: louis.sun338@gmail.com Phone: (305) 7413388

Related Public Records

Same Entity

Unilene, SAC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0014-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Similar Registrations

Registration Number	Establishment Name	Location
8021995	FLEXICARE MEDICAL LTD.	RHONDDA CYNON TAFF Wales, GB
3014208300	HITEC MEDICAL CO., LTD	Shanghai, CN
3016458361	SHAOXING REBORN MEDICAL DEVICES CO.,LTD	Shaoxing Zhejiang, CN
3031369651	HSINER CO., LTD.	Taichung City, TW
3004134948	ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.	Huzhou City Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004845555. Last updated year: 2026. Please use registration number 3004845555 when referencing this establishment in official correspondence.