INSORB REF2030

GUDID 10867516000101

INSORB Subcuticular Skin Stapler REF2030 (each)

INCISIVE SURGICAL, INC.

Skin stapler/staple, bioabsorbable
Primary Device ID10867516000101
NIH Device Record Key12d5ab9c-2728-4bf2-a556-667fd2c6f1ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameINSORB
Version Model Number2030
Catalog NumberREF2030
Company DUNS014099662
Company NameINCISIVE SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100867516000104 [Primary]
GS110867516000101 [Package]
Contains: 00867516000104
Package: Carton [6 Units]
In Commercial Distribution

FDA Product Code

GDWStaple, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-14

On-Brand Devices [INSORB]

00867516000111INSORB Subcuticular Skin Stapler REF1008 (each)
10867516000101INSORB Subcuticular Skin Stapler REF2030 (each)

Trademark Results [INSORB]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSORB
INSORB
97017909 not registered Live/Pending
Incisive Surgical, Inc.
2021-09-08
INSORB
INSORB
86048386 4574769 Live/Registered
AM-AG, LLC
2013-08-26
INSORB
INSORB
76484550 2865571 Live/Registered
Incisive Surgical, Inc.
2003-01-23
INSORB
INSORB
73394904 1293710 Dead/Cancelled
Ja'mi International, Inc.
1982-09-30
INSORB
INSORB
73347020 1235735 Dead/Cancelled
Minnesota Mining and Manufacturing Company
1982-01-25
INSORB
INSORB
72041941 0670835 Dead/Expired
REXALL DRUG COMPANY
1957-12-06

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