FDA.reportPublic FDA data

MTG Pediatric Intermittent Catheter, Coude-tip with hydrophilic low-friction coa

Primary DI
00851593006302
Brand
MTG Pediatric Intermittent Catheter, Coude-tip with hydrophilic low-friction coa
Company
MEDICAL TECHNOLOGIES OF GEORGIA, INC.
Model
81608
Device description
Pediatric Intermittent Catheter, Coude-tip with hydrophilic coating
Published
2016-09-13
Public version status
Update
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
GBMCatheter, Urethral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111405000BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,Hangzhou Bever Medical Devices Co., Ltd.2012-02-13GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851593006309PackageGS130In Commercial Distribution
20851593006306PackageGS112In Commercial Distribution
00851593006302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085159300630910851593006309
2085159300630620851593006306
00851593006302008515930063028515930063020851593006302

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry; Keep away from direct sunlight
Storage Environment Temperature33 Degrees Fahrenheit120 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
770-788-0763MTGcustomerservice@medtechga.com

Regulatory Flags#

DUNS number
011005491
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851593006432MTG Eagle Board1002018-01-23
00851593006944MTG Jiffy Cath™ Coude - PVP kit216142019-10-30
00851593006951MTG Jiffy Cath™ Coude - PVP kit216142019-10-30
00851593006753MTG Jiffy Cath™ Mini-Pak121122019-09-10
00851593006760MTG Jiffy Cath™ Mini-Pak121142019-09-10
00851593006777MTG Jiffy Cath™ Mini-Pak121162019-09-10
00851593006784MTG Jiffy Cath™201122019-09-10
00851593006791MTG Jiffy Cath™201142019-09-10
00851593006807MTG Jiffy Cath™201162019-09-10
00851593006814MTG Jiffy Cath™ Coude206122019-09-10
00851593006821MTG Jiffy Cath™ Coude206142019-09-10
00851593006838MTG Jiffy Cath™ Coude206162019-09-10
00851593006845MTG Jiffy Cath™211142019-09-10
00851593006852MTG Jiffy Cath™221122019-09-10
00851593006869MTG Jiffy Cath™221142019-09-10
00851593006876MTG Jiffy Cath™221162019-09-10
00851593006883MTG Jiffy Cath™ Coude226122019-09-10
00851593006890MTG Jiffy Cath™ Coude226142019-09-10
00851593006906MTG Jiffy Cath™ Coude226162019-09-10
00851593006913MTG Jiffy Cath™ Soft / Coude227122019-09-10

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