FDA.report

BR Surgical, LLC

Primary DI
00840183526207
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR08-56022
Catalog number
BR08-56022
Device description
BRAUN-STADLER Episiotomy Scissors, 8 3/4"
Published
2024-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00840183526207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183526207008401835262078401835262070840183526207

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
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags

DUNS number
134781207
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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