FDA.report

Gen2

Primary DI
00840343701024
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2G16100
Catalog number
G2G16100
Device description
POTTS TENOTOMY SCISSOR, 5-1/2"
Published
2022-10-19
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
LRWScissors, General, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G277G2G161000PreviousHIBCC0
00840343701024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343701024008403437010248403437010240840343701024

GMDN Terms

TermDefinition
TenotomeA small, narrow-bladed knife mounted on a slender handle; usually used to cut a tendon. This GMDN code is sometimes applied to fine scissors, often adapted with a spring-like mechanism to keep the scissors open, used to cut tendons. This is a reusable device.

Device Sizes

TypeValueUnit
Length5.5Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-247-0477customerservice@surgixmedical.com

Regulatory Flags

DUNS number
080402644
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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