BIRD

Primary DI
00860011750215
Brand
BIRD
Company
Gaylord Solutions LLC
Model
EMD0003
Catalog number
EMD0003
Device description
Breast Implant Removal Device, 2 Pack
Published
2024-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QVSBreast Implant Suction Retrieval Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVSBreast Implant Suction Retrieval DeviceGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220082000Breast Implant Removal Device (BIRD)Gaylord Solutions, LLC2023-04-20QVS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011750215PrimaryGS10
00860011750222Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011750215008600117502158600117502150860011750215
00860011750222008600117502228600117502220860011750222

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical suction system, vacuumAn assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119212577
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071153014Explant ExpressAPPLIED MEDICAL TECHNOLOGY, INC.QVS2026-02-25