FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331169915
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
OP7111-54
Catalog number
OP7111-54
Device description
castroviejo caliper, graduated 0 to 20.0 mm, curved shafts
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
HOECaliper, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOECaliper, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331169915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331169915008423311699158423311699150842331169915

GMDN Terms#

Term, Definition table
TermDefinition
FacebowA caliper-like dynamic dental instrument intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. 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
00198506089053ELMED INCORPORATEDELMED INCORPORATEDHOE2026-03-03
00852194002090HAI CaliperHightech American Industrial Labs IncHOE2025-12-16
09348811124524INKAThe Trustee for KAISER FAMILY TRUSTHOE2025-11-28
00810207782575Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00810207782582Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00194613007409MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007423MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007430MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007454MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007508MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613051952MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613112783MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
04058935011055Castroviejo CaliperBausch & Lomb GmbHHOE2025-07-10
04058935011062Castroviejo Marking CaliperBausch & Lomb GmbHHOE2025-07-10
G412PH94030MR PHACOCrestpoint Management LimitedHOE2025-06-09
G412PH94071T0MR PHACOCrestpoint Management LimitedHOE2025-06-09
G412PH9408T0MR PHACOCrestpoint Management LimitedHOE2025-06-09
G2231113910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOE2025-06-04
G412PH20040MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6253MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH9403MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH94080MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH94701T0MR PHACOCrestpoint Management LimitedHOE2025-05-27
G346EB062025SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHOE2025-03-25
00194613007492MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-03-21
00194613049560MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-03-21
00757770407422Bausch + LombBausch & Lomb IncorporatedHOE2024-11-20
00757770419609Bausch + LombBausch & Lomb IncorporatedHOE2024-11-20
00757770423491Bausch + LombBausch & Lomb IncorporatedHOE2024-11-20
00757770424948Bausch + LombBausch & Lomb IncorporatedHOE2024-11-20