Standard Clamp, Disposable SCD25-1

GUDID 00851677007003

STANDARD BARIATRICS, INC

Rigid endoscopic tissue manipulation forceps, single-use
Primary Device ID00851677007003
NIH Device Record Key27546f43-85ad-4d5a-a5f2-4bb11550d6aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Clamp, Disposable
Version Model NumberSCD25-1
Catalog NumberSCD25-1
Company DUNS091278068
Company NameSTANDARD BARIATRICS, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851677007003 [Primary]
GS100851677007010 [Package]
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-08-21
Device Publish Date2017-11-07

On-Brand Devices [Standard Clamp, Disposable ]

00851677007003SCD25-1
00851677007027SCD22-1

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