FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00199150083879
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0907411
Device description
RETRACTOR X0907411 CLOWARD
Published
2026-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199150083879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199150083879001991500838791991500838790199150083879

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150081073Medtronic Reusable InstrumentsX04260042026-07-30
00199150081905Medtronic Reusable InstrumentsX04260022026-07-30
00199150083107Medtronic Reusable InstrumentsEX10040072026-07-30
00763000887216MSB CD HORIZON Spinal System65435352026-07-30
00721902975158GDLH® Posterior Spinal SystemX0196-1112015-08-05
00721902975189GDLH® Posterior Spinal SystemX0196-1222015-08-05
00721902975219GDLH® Posterior Spinal SystemX0196-1262015-08-05
00721902975226GDLH® Posterior Spinal SystemX0196-1282015-08-05
00721902975233GDLH® Posterior Spinal SystemX0196-1302015-08-05
00673978130316GDLH® Posterior Spinal SystemX0196-1042015-08-24
00673978130347GDLH® Posterior Spinal SystemX0196-1072015-08-24
00673978130361GDLH® Posterior Spinal SystemX0196-1092015-08-24
00673978130385GDLH® Posterior Spinal SystemX0196-1122015-08-23
00673978130392GDLH® Posterior Spinal SystemX0196-1142015-08-24
00673978130408GDLH® Posterior Spinal SystemX0196-1162015-08-24
00673978130415GDLH® Posterior Spinal SystemX0196-1182015-08-24
00673978130422GDLH® Posterior Spinal SystemX0196-1202015-08-24
00763000992316INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35262026-07-24
00763000992323INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35282026-07-24
00763000992330INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35302026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083107Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
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00810143904918SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904925SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904932SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904949SURGIPROSSurgipros, LLCGAD2026-07-30
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00810143908824SURGIPROSSurgipros, LLCGAD2026-07-30
00810143908831SURGIPROSSurgipros, LLCGAD2026-07-30
00810143908848SURGIPROSSurgipros, LLCGAD2026-07-30
00810143909609SURGIPROSSurgipros, LLCGAD2026-07-30
00810212930343SURGIPROSSurgipros, LLCGAD2026-07-30
00810212933573SURGIPROSSurgipros, LLCGAD2026-07-30