FDA.report

OctoBase™

Primary DI
20763000284897
Brand
OctoBase™
Company
MEDTRONIC, INC.
Model
28707
Device description
INSERTS 28707 RETRACTOR DPSH 10PK 31L
Published
2026-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20763000284897PackageGS110In Commercial Distribution
00763000284893PrimaryGS10

GMDN Terms

TermDefinition
Operative-site suture holderA device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
006261481
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
false

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00763000823580NAHY11W68R32023-01-14
00763000823597NAHY11N74R142023-01-14
00763000823795NAHY12A49R12023-01-15

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00198506089671ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-17
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