Wide Blade Super Slide Retractor Set 7329-400

GUDID 00840199501069

Wide Blade Super Slide Retractor Set, Consists of the Following: 1x 7329-410 - Wide Blade Retractor Frame 2x 7329-420 - Wide Blunt Blade 2 x 2 1/8", 2x 7329-422 - Wide Blunt Blade 2 x 3 1/8", 2x 7329-424 - Wide Blunt Blade 2 x 4 1/8", 2x 7329-430 - Wide Blade w/teeth 2 x 4 1/8", 2x 7329-432 - Wide Blade w/teeth 1 3/4 x 4 3/4", 2x 7329-434 - Wide Blade w/teeth 2 1/2 x 5 1/2", 1x 7329-440 - Sacral Blade, Left 2 x 3 1/2", 1x 7329-442 - Sacral Blade, Right 2 x 3 1/2", 1x 7329-444 - Sacral Blade, Left 2 3/4 x 2 1/2", 1x 7329-446 - Sacral Blade, Right 2 3/4 x 2 1/2", 1x 7329-448 - Sacral Blade, Left 3 x 3 ", 1x 7329-450 - Sacral Blade, Right 3 x 3 ", 2x 7329-460 - Unilateral Blade Head, 2x 7329-462 - Unilateral T-Blade 2 1/2", 1x 7329-470 - Wide Blade Retractor Case,

KOROS U.S.A., INC.

Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable
Primary Device ID00840199501069
NIH Device Record Key80212a68-34f8-44da-8a31-a05ef8ba065f
Commercial Distribution StatusIn Commercial Distribution
Brand NameWide Blade Super Slide Retractor Set
Version Model Number7329-400
Catalog Number7329-400
Company DUNS007928633
Company NameKOROS U.S.A., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
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

Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100840199501069 [Direct Marking]
GS110840199501066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZTRetractor, Self-Retaining, For Neurosurgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

[00840199501069]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-21
Device Publish Date2021-06-11

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00840199515462 - Drill Guide2024-06-10 Cervical Vert Distraction Drill Guide (Left)
00840199515479 - Drill Guide2024-06-10 Drill Guide
00840199516216 - Nerve Stimulator Probe2024-06-10 Nerve Stimulator Dilator Probe 5.5mm
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00840199517268 - Lamina Spreader2024-06-10 Laminia Spread 16mm,7.5cm dp
00840199517275 - Lamina Spreader2024-06-10 Angled Lamina Spreader w/4 Teeth 10mm wide, 12"/31cm overall length, 7.5cm Deep
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