FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586UR96107170
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
UR96107-17
Catalog number
UR96107-17
Device description
zenith hill-ferguson rectal retractor, 1 7/16" x 3-1/8" (3.6 cm x 7.9 cm) blade
Published
2023-12-18
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGNRETRACTOR, NON-SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586UR96107170PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)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
09348811023018INKAThe Trustee for KAISER FAMILY TRUSTFGN2026-03-16
B382SD1471020010Surgical DirectSurgical Direct, Inc.FGN2026-02-16
B382SD934117790Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117800Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117810Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117820Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117830Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD711510000Surgical DirectSurgical Direct, Inc.FGN2025-08-11
B382SD722510000Surgical DirectSurgical Direct, Inc.FGN2025-08-11
B382SD914781140Surgical DirectSurgical Direct, Inc.FGN2025-07-23
B382SD914173650Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417810000Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417810010Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417811010Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD9141801050Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD4834150Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4861300Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4861400Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4862150Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4871160Surgical DirectSurgical Direct, Inc.FGN2025-07-02
00810123209361Adler Instrument CompanyAdler, Inc.FGN2025-05-23
B382SD147091530Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691000Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691010Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691020Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691030Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD1417812200Surgical DirectSurgical Direct, Inc.FGN2025-02-20
B382SD1417812310Surgical DirectSurgical Direct, Inc.FGN2025-02-20
00840319757611Hayden MedicalHayden Medical, Inc.FGN2025-01-10
00840319757628Hayden MedicalHayden Medical, Inc.FGN2025-01-10