Strauss Surgial

GUDID 00850024135277

AMERICAN MEDICAL ENDOSCOPY, INC.

Needle holder, reusable Needle holder, reusable Needle holder, reusable Needle holder, reusable
Primary Device ID00850024135277
NIH Device Record Key65c2558c-3b59-427c-adf6-f7848b74911e
Commercial Distribution StatusIn Commercial Distribution
Brand NameStrauss Surgial
Version Model NumberSTS-LAP-125-53LTCS
Company DUNS024725124
Company NameAMERICAN MEDICAL ENDOSCOPY, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850024135277 [Primary]
GS100850024135277 [Primary]
GS100850024135277 [Primary]
GS100850024135277 [Primary]

FDA Product Code

FHQHolder, Needle, Gastroenterologic
FHQHolder, Needle, Gastroenterologic
FHQHolder, Needle, Gastroenterologic
FHQHolder, Needle, Gastroenterologic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850024135277]

Moist Heat or Steam Sterilization


[00850024135277]

Moist Heat or Steam Sterilization


[00850024135277]

Moist Heat or Steam Sterilization


[00850024135277]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by AMERICAN MEDICAL ENDOSCOPY, INC.

00850024135000 - Strauss Surgical2020-11-10
00850024135017 - Strauss Surgical2020-11-10
00850024135024 - Strauss Surgical2020-11-10
00850024135031 - Strauss Surgical2020-11-10
00850024135048 - Strauss Surgical2020-11-10
00850024135055 - Strauss Sugical2020-11-10
00850024135062 - Strauss Surgical2020-11-10
00850024135079 - Strauss Surgical2020-11-10

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