FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331183676
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
OB6421-31
Catalog number
OB6421-31
Device description
"collin pelvimeter, graduated in centimeters, 13 3/4"" (35.0 cm)"
Published
2022-11-14
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
HERPelvimeter, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HERPelvimeter, ExternalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331183676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331183676008423311836768423311836760842331183676

GMDN Terms#

Term, Definition table
TermDefinition
PelvimeterA measuring device used to determine the pelvic dimensions. This is typically the internal/external measurement of the pelvis, its diameters and capacity and is usually used in conjunction with gynaecological treatment/intervention. 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
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
G586OB6421210Novo SurgicalNOVO SURGICAL, INC.HER2023-12-18
G586OB6421410Novo SurgicalNOVO SURGICAL, INC.HER2023-12-18
G586OB96421410Novo SurgicalNOVO SURGICAL, INC.HER2023-12-18
04038653154951AESCULAPAesculap AGHER2020-05-08
04038653154975AESCULAPAesculap AGHER2020-05-08
10381780495079Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
10381780495086Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
H8343022300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
H8343022350Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
10885403046735V. MuellerSTERIS CORPORATIONHER2018-08-30
10381780203056Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16
10381780409328Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16
M274X4133461Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16
M2745101301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16