Bullet Tip Adapter

GUDID 00858406007150

SURGENTEC, LLC

Orthopaedic cement dispenser
Primary Device ID00858406007150
NIH Device Record Keyb1153f18-8116-47c5-b914-79b30d2b6e45
Commercial Distribution StatusIn Commercial Distribution
Brand NameBullet Tip Adapter
Version Model NumberGG-NTA-03
Company DUNS004095409
Company NameSURGENTEC, LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858406007150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


[00858406007150]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-24
Device Publish Date2025-03-14

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00850040139495 - ALARA® 11 Gauge Access Needle Two Pack- Bevel Tip2025-05-07
00850040139501 - ALARA® 11 Gauge Access Needle Two Pack- Diamond & Bevel Tip2025-05-07
00850040139518 - ALARA® 11 Gauge Access Needle Two Pack- Diamond Tip2025-05-07
00850040139525 - ALARA® 11 Gauge Access Needle with Sheath - Bevel Tip2025-05-07

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