FDA.reportPublic FDA data

ERBE

Primary DI
04050147013094
Brand
ERBE
Company
Erbe Elektromedizin GmbH
Model
20350-000
Device description
ERBELIFT® Hand Pump
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FBKEndoscopic Injection Needle, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050147013094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050147013094040501470130944050147013094

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic needleless submucosal lift pumpA non-sterile, hand-held, manually-powered device designed to push a submucosal lifting solution, via an endoscopic needleless submucosal lift catheter, into the submucosa of the gastrointestinal tract during an endoscopic procedure (e.g., gastroscopy, colonoscopy) to lift a lesion, typically for subsequent excision. It is typically a pistol-shaped instrument, into which is loaded a standard prefilled syringe, designed to achieve high injection pressure. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat and direct sunlight
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050147024694Erbe20402-5012026-05-26
04050147023925Erbe20132-32520132-2572025-08-01
04050147024540Erbe20132-25720132-2572025-05-20
04050147024410Erbe20132-25020132-2502025-04-29
04050147024441Erbe20132-25120132-2512025-04-29
04050147024465Erbe20132-25220132-2522025-04-29
04050147024489Erbe20132-25320132-2532025-04-29
04050147024502Erbe20132-25420132-2542025-04-29
04050147024526Erbe20132-25520132-2552025-04-29
04050147024564Erbe20132-25620132-2562025-04-29
04050147023529Erbe20160-01120160-0112025-04-07
04050147023581Erbe20132-32120132-3212025-02-11
04050147023666Erbe20132-32320132-3232025-02-11
04050147023642Erbe20132-32420132-3242025-02-11
04050147022751Erbe20220-10020220-1002025-01-21
04050147022768Erbe20220-11020220-1102025-01-21
04050147022775Erbe20220-00020220-0002025-01-21
04050147022782Erbe20220-01020220-0102025-01-21
04050147023543Erbe20220-00120220-0012025-01-21
04050147023550Erbe20220-01120220-0112025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800035704711CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704728CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704841CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704858CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704865CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704872CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704889CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704896CORE-INJECTORINCORE CO., LTDFBK2026-02-06
06974296705915AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296706004AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296706479AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707131AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707285AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707377AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707315AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707322AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707339AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707346AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707353AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707360AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06942127812477AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06942127815362AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671385963AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671385994AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671386144AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671386175AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
05420051305209G-FlexG-Flex EuropeFBK2025-06-02
05420051305216G-FlexG-Flex EuropeFBK2025-06-02
05420051305247G-FlexG-Flex EuropeFBK2025-06-02
05420051306008G-FlexG-Flex EuropeFBK2025-06-02