FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331127403
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
UR6208-88
Catalog number
UR6208-88
Device description
zipser penile clamp
Published
2022-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00842331127403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331127403008423311274038423311274030842331127403

GMDN Terms#

Term, Definition table
TermDefinition
Surgical penile clampA manual surgical instrument with two blades that are joined at their midpoint, or made of a single alpha-shaped part, intended to stop blood flow to the penis. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1877-860-6686info@novosurgical.com

Regulatory Flags#

DUNS number
033029433
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G586N6863510Novo SurgicalN6863-51N6863-512023-12-18
G586N6863530Novo SurgicalN6863-53N6863-532023-12-18
G586N6863540Novo SurgicalN6863-54N6863-542023-12-18
G586N6863550Novo SurgicalN6863-55N6863-552023-12-18
G586N6863580Novo SurgicalN6863-58N6863-582023-12-18
G586N6863590Novo SurgicalN6863-59N6863-592023-12-18
G586N98831250Novo SurgicalN98831-25N98831-252023-12-18
00842331174377Novo Surgical Inc. N3807-12N3807-122022-11-14
00842331153556Novo Surgical Inc. N6863-52N6863-522022-11-12
00842331165771Novo Surgical Inc. N6863-56N6863-562022-11-13
00842331169717Novo Surgical Inc. N6863-57N6863-572022-11-13
00842331170836Novo Surgical Inc. N3807-13N3807-132022-11-13
00842331194023Novo Surgical Inc. OP7195-242023-12-07
G586NS41500200Novo SurgicalNS4150020NS41500202025-09-15
G586NS41500250NovosurgicalNS4150025NS41500252025-09-15
G586NS720151200Novo SurgicalNS720-1512-02025-09-15
G586NS720155800Novo Surgical IncNS720-1558-0NS720-1558-02025-09-15
00842331192968Novo Surgical IncG1911-38IG-NS2023-08-21
G586NS80292210Novo SurgicalNS80-2922-1NS80-2922-12025-05-19
G586N8810500Novo SurgicalN8810-502025-05-19

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
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
00653599000007KindKlampARGENTUM MEDICAL, LLCFHA2020-01-22