FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331167317
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
UR6185-83
Catalog number
UR6185-83
Device description
alan-parks rectal retractor, large lateral blades, pair, 22.0 x 95.0 mm
Published
2022-11-13
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
FFORetractor, Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331167317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331167317008423311673178423311673170842331167317

GMDN Terms#

Term, Definition table
TermDefinition
Sterilizer transfer forcepsA hand-held, scissors-like, manual surgical instrument whose blades, distal to the pivot point, form open circles, loops, or ellipses designed to grasp and handle sterile instruments, packages, or implants, especially directly from a sterilizer. It is typically made of high-grade stainless steel. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842102116421Bookler Table Mounted Retractor SystemsFLEXBAR MACHINE CORPORATIONFFO2026-03-19
09348811023667INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-03-16
00192896122765Balfour Deluxe RetractorSONTEC INSTRUMENTS, INC.FFO2026-03-10
B382SD4942000Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942010Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942020Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942030Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942040Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942050Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942060Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942070Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942080Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942090Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942100Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942110Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942120Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942130Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942140Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942150Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942160Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942170Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942180Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942190Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942200Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942210Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD494222Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD494223Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942240Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942250Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942260Surgical DirectSurgical Direct, Inc.FFO2026-03-02