FDA.report

m-protect3

Primary DI
04262358420060
Brand
m-protect3
Company
qtec CE-med GmbH
Model
31/32
Catalog number
MP0031/32-12
Device description
m-protect®3 is intended exclusively for use as an insertion guide of circular stapler instruments used for transanal stapled anastomosis.
Published
2023-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KOASurgical Instruments, G-U, Manual (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04262358420060PackageGS112In Commercial Distribution
04262358420121PackageGS110In Commercial Distribution
04262358420039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04262358420060042623584200604262358420060
04262358420121042623584201214262358420121
04262358420039042623584200394262358420039

GMDN Terms

TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep dry, keep away from sunlight
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+4945180850360info@qtec-group.com

Regulatory Flags

DUNS number
344010844
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04262358420022m-protect328/29MP0028/29-122023-07-17
04262358420077m-protect333/34MP0033/34-122023-07-17
04262358420091FisturasperM+LFR0032023-07-17
04262358420015FisturasperS-XLFR0012023-07-16

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