FDA.reportPublic FDA data

Keller Funnel 2

Primary DI
10888628043725
Brand
Keller Funnel 2
Company
Allergan, Inc.
Model
HA-005
Catalog number
HA-005
Device description
Silicone Breast Implant Insertion Device
Published
2022-12-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDDKit, Surgical Instrument, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888628043725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088862804372510888628043725

GMDN Terms#

Term, Definition table
TermDefinition
Breast implant delivery sleeveA sterile flexible cylinder intended to assist with the delivery of a prefilled breast implant by providing a low-friction shell-tissue interface during implant insertion into a surgically-created breast pocket, without constricting the size of the implant. It is typically made of polyethylene (PE) plastic and is not intended to be used with a lubricant other than saline. The implant is directed through the tube by twisting of the distal end, or by direct manual manipulation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-624-4261AGN-DL-AUS-ProductSupport@abbvie.com

Regulatory Flags#

DUNS number
144796497
Device count
1
Premarket exempt
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888628047474XEN Glaucoma Treatment System5513-0015513-0012026-07-17
10888628031432Natrelle Inspira ST Resterilizable SizersMSZST-L110MSZST-L1102016-10-04
10888628031449Natrelle Inspira ST Resterilizable SizersMSZST-L125MSZST-L1252016-10-04
10888628031456Natrelle Inspira ST Resterilizable SizersMSZST-L140MSZST-L1402016-10-04
10888628031463Natrelle Inspira ST Resterilizable SizersMSZST-L170MSZST-L1702016-10-04
10888628031470Natrelle Inspira ST Resterilizable SizersMSZST-L200MSZST-L2002016-10-04
10888628031487Natrelle Inspira ST Resterilizable SizersMSZST-L230MSZST-L2302016-10-04
10888628031494Natrelle Inspira ST Resterilizable SizersMSZST-L260MSZST-L2602016-10-04
10888628031500Natrelle Inspira ST Resterilizable SizersMSZST-L290MSZST-L2902016-10-04
10888628031517Natrelle Inspira ST Resterilizable SizersMSZST-L320MSZST-L3202016-10-04
10888628031524Natrelle Inspira ST Resterilizable SizersMSZST-L350MSZST-L3502016-10-04
10888628031531Natrelle Inspira ST Resterilizable SizersMSZST-L380MSZST-L3802016-10-05
10888628031548Natrelle Inspira ST Resterilizable SizersMSZST-L410MSZST-L4102016-10-05
10888628031555Natrelle Inspira ST Resterilizable SizersMSZST-L460MSZST-L4602016-10-05
10888628031562Natrelle Inspira ST Resterilizable SizersMSZST-L510MSZST-L5102016-10-05
10888628031579Natrelle Inspira ST Resterilizable SizersMSZST-L560MSZST-L5602016-10-05
10888628031586Natrelle Inspira ST Resterilizable SizersMSZST-L610MSZST-L6102017-03-20
10888628031593Natrelle Inspira ST Resterilizable SizersMSZST-LP125MSZST-LP1252016-10-05
10888628031609Natrelle Inspira ST Resterilizable SizersMSZST-LP145MSZST-LP1452016-10-05
10888628031616Natrelle Inspira ST Resterilizable SizersMSZST-LP165MSZST-LP1652016-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756400442DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-21
00749756394666DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756397193DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401708DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401715DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00889795154668Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154675Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154682Primal OCDParagon 28, Inc.KDD2026-07-14
20653405990328Infinity™Conmed CorporationKDD2026-06-10
08800071700500TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
10080196042777MEDLINEMEDLINE INDUSTRIES, INC.KDD2025-06-02
B562PKGS000100Micro Surgery KitWishbone Medical, Inc.KDD2024-12-30
B562PKGS000200Minor Surgery KitWishbone Medical, Inc.KDD2024-12-30
08800071700166Tiger GuardKims Med Co.,Ltd.KDD2024-10-21
08800071700111Tiger GuardKims Med Co.,Ltd.KDD2024-07-30
10193489951936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2024-07-29
08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
00811870037979Manus Medical, LLCManus Medical, LLCKDD2024-02-06
10195327271626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327271770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327264192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327265762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
08800071700050EZ Fan Funnel 2KimsMed Co.,Ltd.KDD2023-02-06
10195327271633Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-12-18
10885380194108Aero-MedAERO-MED, LLCKDD2022-12-15