FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331143199
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
OB6346-10
Catalog number
OB6346-10
Device description
hegar uterine dilator, double-ended, 7 1/2" (19.1 cm), 9.0 mm / 10.0 mm
Published
2022-11-11
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
HDQDilator, Cervical, Fixed Size

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331143199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331143199008423311431998423311431990842331143199

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417789MillenniumAvalign Technologies, Inc.HDQ2026-03-11
00198506088230ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506088247ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506088254ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506088261ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506087981ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506087998ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088001ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088018ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088025ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088032ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088049ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
04262494463143N/ADoppkon GmbH & Co. KGHDQ2025-12-04
04262494462986N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494462993N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463006N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463013N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463020N/ADoppkon GmbH & Co. KGHDQ2025-12-01
00190776411671MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411688MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411695MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411732MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411749MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411756MillenniumAvalign Technologies, Inc.HDQ2025-09-25
00190776411459MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411466MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411596MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411602MillenniumAvalign Technologies, Inc.HDQ2025-09-24
00190776411435MillenniumAvalign Technologies, Inc.HDQ2025-09-22
00190776411442MillenniumAvalign Technologies, Inc.HDQ2025-09-22