Key Surgical Hemostasis Clips

GUDID 10849771039225

Hemostasis Clip, Rotatable, Single-Use, Coated, 16mm (Opening) W

KEY SURGICAL, INC.

Gastrointestinal endoscopic clip, short-term
Primary Device ID10849771039225
NIH Device Record Keyeed7c0aa-a249-4d4d-89b0-1e806b338416
Commercial Distribution StatusIn Commercial Distribution
Brand NameKey Surgical Hemostasis Clips
Version Model NumberEN10400A.16
Company DUNS604056226
Company NameKEY SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005417995
Email[email protected]

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771039204 [Primary]
GS100849771039228 [Package]
Contains: 00849771039204
Package: Box [5 Units]
In Commercial Distribution
GS110849771039225 [Package]
Contains: 00849771039228
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKLHemostatic Metal Clip For The Gi Tract

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [Key Surgical Hemostasis Clips]

10849771039225Hemostasis Clip, Rotatable, Single-Use, Coated, 16mm (Opening) W
10849771039195Hemostasis Clip, Rotatable, Single-Use, Coated, 11mm (Opening) W

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