II Ring Retractor 1546 00 SS

GUDID 00810118341663

Balfour Retractor 3" x 2"

Automated Medical Products Corp.

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 Surgical retractor/retraction system blade, reusable
Primary Device ID00810118341663
NIH Device Record Key05c1a64f-a6bc-4203-92f4-c3f05bd27e63
Commercial Distribution StatusIn Commercial Distribution
Brand NameII Ring Retractor
Version Model NumberBalfour Retractor 3" x 2"
Catalog Number1546 00 SS
Company DUNS053435368
Company NameAutomated Medical Products Corp.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118341663 [Primary]

FDA Product Code

GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

[00810118341663]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-06
Device Publish Date2023-05-29

On-Brand Devices [II Ring Retractor]

00810118343001Balfour Swivel Retractor 3 1/4" x 2 3/4" Aluminum/Radiolucent
00810118342998Balfour Swivel Retractor 2 1/2" x 2 3/4" Aluminum/Radiolucent
00810118342981Balfour Swivel Retractor 4 1/2" x 2 1/2" Aluminum/Radiolucent
00810118342974Balfour Swivel Retractor 4" x 2 1/4" Aluminum/Radiolucent
00810118342967Balfour Swivel Retractor 3 1/4" x 2 1/4" Aluminum/Radiolucent
00810118342950Kelly 1" x 6" Retractor Aluminum/Radiolucent
00810118342943Kelly 1" x 5" Retractor Aluminum/Radiolucent
00810118342936Kelly 1" x 4" Retractor Aluminum/Radiolucent
00810118342929Kelly 1" x 3" Retractor Aluminum/Radiolucent
00810118342912Kelly 2" x 2" Retractor Aluminum/Radiolucent
00810118342905Kelly 2" x 8" Retractor Aluminum/Radiolucent
00810118342899Kelly 2" x 7" Retractor Aluminum/Radiolucent
00810118342882Kelly 2" x 6" Retractor Aluminum/Radiolucent
00810118342875Kelly 2" x 5" Retractor Aluminum/Radiolucent
00810118342868Kelly 2" x 4" Retractor Aluminum/Radiolucent
00810118342851Kelly 2" x 3" Retractor Aluminum/Radiolucent
00810118342844Rake 4-Prong with Rotation 3/4” x 7/8”
00810118342837Rake 3-Prong with Rotation 5/8” x 7/8”
00810118342820Hook Urology, Single Prong
00810118342813IMA Cross-bar 12"
00810118342806IMA Hook
00810118342790Replacement Screw for all Segmented Rings
00810118342783Straight Segments Large 8” Sold in Pairs
00810118342776Straight Segments Medium 6” Sold in Pairs
00810118342769Straight Segments Small 4” Sold in Pairs
00810118342752Segmented Round Ring Large 12.5” Diameter
00810118342745Segmented Round Ring Medium 10.5” Diameter
00810118342738Segmented Round Ring Small 8.5” Diameter
00810118342721Segmented Perineal Ring Notched 9.5” x 13.5”
00810118342714Segmented Elliptical Ring 14” x 15”
00810118342707Segmented Oval Ring Large 12.5" x 19"
00810118342691Segmented Oval Ring Medium 10.5" x 19"
00810118342684Segmented Oval Ring Small 8.5" x 14"
00810118342677Round Ring Large 12.5”
00810118342660Round Ring Medium 10.5”
00810118342653Round Ring Small 8.5”
00810118342646Oval Ring Large 12” x 18.5”
00810118342639Oval Ring Large 12” x 18.5” Titanium/Radiolucent
00810118342622Oval Ring Medium 10.5” x 14.5”
00810118342615Oval Ring Medium 10.5” x 14.5” Titanium/Radiolucent
00810118342608Oval Ring Small 8” x 12.5”
00810118342592Oval Ring Small 8” x 12.5” Titanium/Radiolucent
00810118342585Richardson Retractor 1" x 1 1/2"
00810118342578Goulet Retractor Small 1 1/4" x 1 1/4”
00810118342561Right Angled Retractor 1/2” x 1 1/2"
00810118342554Right Angled Retractor 1/2” x 1"
00810118342547Skin Rake Retractor 6-Prong 1" W x 1/3" D Titanium/Radiolucent
00810118342530Skin Rake Retractor 6-Prong 1" W x 1/3" D
00810118342523Skin Rake Retractor 4-Prong 3/4" W x 1/3" D Titanium/Radiolucent
00810118342516Skin Rake Retractor 4-Prong 3/4" W x 1/3" D
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.