Sigma

GUDID 00190376270760

110mm C-C BLADE, SIGMA

ALPHATEC SPINE, INC.

Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable
Primary Device ID00190376270760
NIH Device Record Key8027dd59-4b8d-466f-a3b6-100318a8c93c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSigma
Version Model Number269-100-110
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190376270760 [Primary]
GS100190376270760 [Primary]
GS100190376270760 [Primary]
GS100190376270760 [Primary]
GS100190376270760 [Primary]
GS100190376270760 [Primary]
GS100190376270760 [Primary]
GS100190376270760 [Primary]

FDA Product Code

GADRETRACTOR
GADRETRACTOR
GADRETRACTOR
GADRETRACTOR
GADRETRACTOR
GADRETRACTOR
GADRETRACTOR
GADRETRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190376270760]

Moist Heat or Steam Sterilization


[00190376270760]

Moist Heat or Steam Sterilization


[00190376270760]

Moist Heat or Steam Sterilization


[00190376270760]

Moist Heat or Steam Sterilization


[00190376270760]

Moist Heat or Steam Sterilization


[00190376270760]

Moist Heat or Steam Sterilization


[00190376270760]

Moist Heat or Steam Sterilization


[00190376270760]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Sigma]

00190376276311Sigma TLIF Access System
00190376276267Sigma TLIF A-Arm
00190376279169LATERAL ARM, RIGHT
00190376279152LATERAL ARM, LEFT
00190376270784SMALL MEDIAL BLADE, SIGMA
00190376270777120mm C-C BLADE, SIGMA
00190376270760110mm C-C BLADE, SIGMA
00190376270753100mm C-C BLADE, SIGMA
0019037627074690mm C-C BLADE, SIGMA
0019037627073980mm C-C BLADE, SIGMA
0019037627072270mm C-C BLADE, SIGMA
0019037627071560mm C-C BLADE, SIGMA
0019037627070850mm C-C BLADE, SIGMA
00190376270692XL MEDIAL BLADE, SIGMA
00190376270685LARGE MEDIAL BLADE, SIGMA
00190376270678MEDIUM MEDIAL BLADE, SIGMA
00190376270166SIGMA RETRACTOR
00190376270142COBB, SIGMA
00190376270135SPLAY KNOB DRIVER, SIGMA
00190376270128ACCESS HEX DRIVER, T-HANDLE, SIGMA
00190376270111T25 BALL-HEX DRIVER, IN-LINE, SIGMA
00190376270104MEDIAL BLADE INSERTER, SIGMA

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