FDA.reportPublic FDA data

CATHETER

Primary DI
00888118057686
Brand
CATHETER
Company
KLS-Martin L.P.
Model
36-321-01-01
Published
2018-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBYCATHETER, EUSTACHIAN, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBYCatheter, Eustachian, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118057686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118057686008881180576868881180576860888118057686

GMDN Terms#

Term, Definition table
TermDefinition
Eustachian catheter, reusableA long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown from an external bag through the device and into the middle ear. It is typically made of soft metals [e.g., silver (Ag) coated brass], and has a curved distal end with a slightly bulbous tip and a wider funnel-like proximal end with a finger ring to aid manipulation. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118108357DISTRACTION, INTERNAL, STERILE51-556-20-812018-09-26
00888118108364DISTRACTION, INTERNAL, STERILE51-557-20-812018-09-26
00888118147226LEVEL ONE EXTREMITY26-950-64-042026-07-21
00888118147233LEVEL ONE EXTREMITY26-950-65-042026-07-21
00888118147240LEVEL ONE EXTREMITY26-950-66-042026-07-21
00888118147257LEVEL ONE EXTREMITY26-950-67-042026-07-21
00888118147264LEVEL ONE EXTREMITY26-950-68-042026-07-21
00888118147271LEVEL ONE EXTREMITY26-950-69-042026-07-21
00888118147714LEVEL ONE EXTREMITY26-950-58-042026-07-21
00888118147721LEVEL ONE EXTREMITY26-950-59-042026-07-21
00888118147738LEVEL ONE EXTREMITY26-950-62-042026-07-21
00888118147745LEVEL ONE EXTREMITY26-950-63-042026-07-21
00888118154620LEVEL ONE CMF25-315-92-912026-07-21
00888118154637LEVEL ONE CMF50-743-06-092026-07-21
00888118154644LEVEL ONE, STERILE25-433-97-712026-07-21
00888118154651LEVEL ONE, STERILE25-438-97-712026-07-21
00888118154668LEVEL ONE, STERILE25-439-91-712026-07-21
00888118154675LEVEL ONE, STERILE25-486-97-712026-07-21
00888118154682LEVEL ONE, STERILE25-487-97-712026-07-21
00888118154699LEVEL ONE, STERILE50-817-15-712026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653176243AESCULAPAesculap AGGBY2020-04-22
04038653176250AESCULAPAesculap AGGBY2020-04-22
04038653176267AESCULAPAesculap AGGBY2020-04-22
04038653176281AESCULAPAesculap AGGBY2020-04-22
00888118057693CATHETERKLS-Martin L.P.GBY2018-09-26
00888118057709CATHETERKLS-Martin L.P.GBY2018-09-26
10381780402916Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
10381780402923Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
M274X203531Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
M274X203571Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
10381780419327Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2017-12-21
10381780419334Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2017-12-21
H834192420Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2017-12-21
H834192460Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2017-12-21