FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403050107
Brand
V. Mueller
Company
STERIS CORPORATION
Model
GU4560
Catalog number
GU4560
Device description
HYAMS MEATUS CLAMP
Published
2018-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHACLAMP, PENILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHAClamp, PenileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403050107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540305010710885403050107

GMDN Terms#

Term, Definition table
TermDefinition
Surgical penis clamp, reusableA hand-held manual surgical instrument designed to grasp the penis for manipulation during surgery (e.g., circumcision). It is typically a clip-like device e.g., with self-retaining levers. The penis is placed into this clamp that closes around or on the organ. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613105082MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-08-01
04049047064947GimmiGimmi GmbHFHA2025-05-20
00194613031305MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613103484MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613106959MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613111113MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613061531MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2024-08-15
00887482075333Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.FHA2024-08-15
04049197264655RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFHA2024-06-28
04049197264662RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFHA2024-06-28
00840183523008BR Surgical, LLCBR Surgical, LLCFHA2024-06-10
00653599002179KindKlampARGENTUM MEDICAL, LLCFHA2024-02-07
G586UR96208880Novo SurgicalNOVO SURGICAL, INC.FHA2023-12-18
00842962125977HNM MEDICALHNM STAINLESS, LLC.FHA2023-04-12
B974ZC1100PENIS CLAMPDR.FRIGZ INTERNATIONAL(PVT)LTD,FHA2022-11-21
08800064400004Jeato Incontinence ClampJeato Med. CO., Ltd.FHA2022-11-14
08800064400103Jeato 7 Incontinence Clamp Jeato Med. CO., Ltd.FHA2022-11-14
00842331127403Novo Surgical Inc. NOVO SURGICAL, INC.FHA2022-11-09
00887482076101Symmetry VasASPEN SURGICAL PRODUCTS, INC.FHA2022-09-21
00887482076194Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.FHA2022-09-21
00653599001660KindKlampARGENTUM MEDICAL, LLCFHA2021-09-20
00190660018443Ambler SurgicalAMBLER SURGICAL CORP.FHA2021-01-04
04046826062989MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFHA2020-09-24
04046826062996MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFHA2020-09-24
00801741049002Penile ClampC. R. Bard, Inc.FHA2020-09-22
00801741050961Penile ClampC. R. Bard, Inc.FHA2020-09-22
00801741072741Incontinence ClampC. R. Bard, Inc.FHA2020-09-04
00801741072758Incontinence ClampC. R. Bard, Inc.FHA2020-09-04
00801741072765Incontinence ClampC. R. Bard, Inc.FHA2020-09-04
04038653039326AESCULAPAesculap AGFHA2020-04-20