FDA.report

N/A

Primary DI
00812185032307
Brand
N/A
Company
SHIPPERT MEDICAL TECHNOLOGIES, INC
Model
3-C-KC-3X35
Published
2019-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812185032307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812185032307008121850323078121850323070812185032307

GMDN Terms

TermDefinition
Liposuction system cannula, single-useA rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
051437143
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

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00893398002004DENVER SPLINT10-1500-05KS2018-09-13
00893398002011DENVER SPLINT10-1500-05KL2018-09-13
00893398002035DENVER SPLINT10-4021-05KS2018-09-13
00893398002042DENVER SPLINT10-4021-05KL2018-09-13
00893398002066DENVER SPLINT10-1500-05KP2018-09-13
00893398002103DENVER SPLINT10-4021-05KM2018-09-13
00893398002110DENVER SPLINT10-4021-10NKM2018-09-20
00893398002127DENVER SPLINT10-4021-10NKL2018-09-20
00893398002530HOTSYCautery High Temperature Fine Tip20-HM-20002016-08-12
00893398002547HOTSYCautery High Temperature Loop Tip20-HM-10002016-08-12
00893398002578DENVER SPLINT10-1500-05KM2018-09-13
00893398002585DENVER SPLINT10-1800-05KL2018-09-13
00893398002592DENVER SPLINT10-1800-05KM2018-09-13
00893398002608DENVER SPLINT10-1800-05KP2018-09-13
00893398002615DENVER SPLINT10-1800-05KS2018-09-13
00893398002622DENVER SPLINT10-2000-05KL2018-09-13
00893398002639DENVER SPLINT10-2000-05KM2018-09-13
00893398002646DENVER SPLINT10-2000-05KP2018-09-13
00893398002653DENVER SPLINT10-2000-05KS2018-09-13
00893398002660DENVER SPLINT10-3000-05KL2018-09-13

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