FDA.report

ERBE

Primary DI
04050147013780
Brand
ERBE
Company
Erbe Elektromedizin GmbH
Model
20350-220
Catalog number
20350-220
Device description
ERBELIFT® Flexible Probe O.D. 1.3mm x 2.6m
Published
2016-12-14
Public version status
Update
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
FBKendoscopic injection needle, gastroenterology-urology

Product Code Classifications

CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050147013773PackageGS15In Commercial Distribution
04050147013780PackageGS116In Commercial Distribution
04050147013100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050147013773040501470137734050147013773
04050147013780040501470137804050147013780
04050147013100040501470131004050147013100

GMDN Terms

TermDefinition
Endoscopic needleless submucosal lift catheterA sterile, flexible tube intended to non-invasively deliver a submucosal lifting solution into the submucosa of the gastrointestinal tract through a flexible endoscope during an endoscopic procedure (e.g., gastroscopy, colonoscopy) to lift a lesion, typically for subsequent excision. It is attached proximally to a dedicated pump and the distal end incorporates a mechanism for producing a very small laminar stream for needleless injection. This is a single-use device.

Device Sizes

TypeValueUnit
Length2600Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat and direct sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods

Method

Contacts

PhoneEmail
+4970717550info@erbe-med.com

Regulatory Flags

DUNS number
316116623
Device count
1
DM exempt
false
Premarket exempt
false
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

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