FDA.reportPublic FDA data

Erbe

Primary DI
04050147024694
Brand
Erbe
Company
Erbe Elektromedizin GmbH
Model
20402-501
Device description
Flexible Cryoprobe; OD 1.7mm, L2.55m
Published
2026-05-26
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253230000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253230000ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH2026-04-22GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050147024700PackageGS15In Commercial Distribution
04050147024694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050147024700040501470247004050147024700
04050147024694040501470246944050147024694

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic cryosurgical probe, single-useA flexible distal component of a cryosurgical system intended to be inserted through the working channel of an endoscope for cryoadhesion and devitalization of tissues during interventional procedures (e.g., bronchoscopy/interventional pulmonology). It is connected at the proximal end to the system control unit whereby gas expansion within the probe tip causes cooling of the tip based on the Joule-Thompson effect. It is typically intended for a variety of surgical applications (e.g., biopsy, recanalization, removal of blood clots). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
+4970717550info@erbegroup.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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04050147023567Erbe20220-10120220-1012025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28
00194346615124EquateWAL-MART STORES, INC.GEH2025-12-22
06935650602042HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650602059HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650602066HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650602073HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603049HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603056HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603063HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603070HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603087HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603094HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
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06935650603131HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603148HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603155HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603162HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603179HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603186HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603193HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603216HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603223HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603230HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603247HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603254HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603209HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-07
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