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
OTC
false
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118150288LEVEL ONE CMF, STERILE50-280-00-712026-10-21
00888118150295LEVEL ONE CMF, STERILE50-280-03-712026-10-21
00888118150301LEVEL ONE CMF, STERILE50-280-05-712026-10-21
00888118150318LEVEL ONE CMF, STERILE50-280-07-712026-10-21
00888118150325LEVEL ONE CMF, STERILE50-280-09-712026-10-21
00888118150332LEVEL ONE CMF, STERILE50-280-11-712026-10-21
00888118150349LEVEL ONE CMF, STERILE50-282-00-712026-10-21
00888118150356LEVEL ONE CMF, STERILE50-282-03-712026-10-21
00888118150363LEVEL ONE CMF, STERILE50-282-05-712026-10-21
00888118150370LEVEL ONE CMF, STERILE50-282-07-712026-10-21
00888118150387LEVEL ONE CMF, STERILE50-282-09-712026-10-21
00888118150394LEVEL ONE CMF, STERILE50-282-11-712026-10-21
00888118150400LEVEL ONE CMF, STERILE50-302-09-712026-10-21
00888118150417LEVEL ONE CMF, STERILE50-302-11-712026-10-21
00888118154910LEVEL ONE CMF25-874-11-612026-10-21
00888118154927LEVEL ONE CMF25-874-11-912026-10-21
00888118154934LEVEL ONE CMF25-874-15-912026-10-21
00888118154941LEVEL ONE CMF25-874-15-612026-10-21
00888118154958LEVEL ONE CMF, STERILE25-874-11-712026-10-21
00888118154965LEVEL ONE CMF, STERILE25-874-15-712026-10-21

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