FDA.report

Novo Surgical

Primary DI
G586OB6441260
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
OB6441-26
Catalog number
OB6441-26
Device description
braun-stadler episiotomy scissors, 6" (15.0 cm)
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

Related Records

Contact Domains

Product Codes

CodeName
HDKSCISSORS, EPISIOTOMY

Product Code Classifications

CodeDeviceSpecialtyClass
HDKScissors, EpisiotomyObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G586OB6441260PrimaryHIBCC0

GMDN Terms

TermDefinition
Episiotomy scissors, reusableA hand-held, manual, obstetrical, surgical instrument intended to cut the outlet of the vagina in childbirth so as to facilitate the birth of the child (also known as perineotomy). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes; the blades are typically angled, have different shapes, and may be serrated. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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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

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