FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331135620
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
UR6274-35
Catalog number
UR6274-35
Device description
van buren urethral sound, curved, 11" (27.9 cm), 24 fr.
Published
2022-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBXSound, Urethral, Metal Or Plastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331135620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331135620008423311356208423311356200842331135620

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal dilatorA firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable 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
DM exempt
false
Premarket exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G586N8810500Novo SurgicalN8810-502025-05-19
G586NS38796080NOVOSURGICALNS38-796-08NS38-796-082025-05-02
G586NS50468110Novo SurgicalNS50-4681-1NS50-4681-12025-05-02
G586G171631E0NovosurgicalG1716-31E2025-04-17
G586G311041NC0Novo SurgicalG3110-41NC2025-03-21
G586N697205A0NovosurgicalN6972-05AN6972-05A2025-02-06
G586N697206A0NovosurgicalN6972-06AN6972-05A2025-02-06
G586NS02533010Novo SurgicalNS02-5330-1NS02-5330-12025-02-06
G586NS5230002SPFB10Novo SurgicalNS52-300-02SPFB-1NS02-5330-12025-02-06
G5862562529S0Novosurgical25625-29S2025-01-02
G586N6969090NovosurgicalN6969-092025-01-02
G586N6971710NovosurgicalN6971-712025-01-02
G586N6971730NovosurgicalN6971-732025-01-02
G586N6972700NovosurgicalN6972-702025-01-02
G586NS47110610NovosurgicalNS47-1106-12025-01-02

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00194613106614MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613106942MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115913MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115920MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115937MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00190776394189MillenniumAvalign Technologies, Inc.FBX2025-05-07
00190776394196MillenniumAvalign Technologies, Inc.FBX2025-05-07
00840183530037BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530044BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530051BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530068BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530075BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530082BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530099BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530020BR Surgical, LLCBR Surgical, LLCFBX2025-04-15
00840183529789BR Surgical, LLCBR Surgical, LLCFBX2025-04-07
00840183529864BR Surgical, LLCBR Surgical, LLCFBX2025-04-07
00194613046507MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613100773MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613103545MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613104221MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613105006MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21